| Developers: | HeartWare International |
| Branches: | Pharmaceuticals, Medicine, Healthcare |
Content |
HVAD System is an auxiliary ventricular system developed by HeartWare International. This device is intended for patients with severe heart failure and can be used as a bridge in heart transplantation.
2023: Medtronic: Hundreds of patients have our heart pumps down
On August 23, 2023, Medtronic announced the identification of several groups of patients who may face a higher risk of problems when using HeartWare Ventricular Assist Device (HVAD) heart pumps.
Said device represents an auxiliary ventricular system intended for patients with severe heart failure. The device can be used as a bridge in heart transplantation. However, in 2021, Medtronic was forced to stop selling HeartWare after a series of reviews related to various problems, including the inability to restart the pump. A new study by the company says that this defect manifests itself more often in individual patients than in others.
It is noted that about 300 people entered the high-risk group. For them, the probability that the heart pump will restart with a delay or not start at all after stopping is 3.3%. For another 38 patients, this figure is 2.7%. The maximum probability of a critical failure, equal to 31%, was detected in a group of 17 people.
The use of defective HeartWare devices can have serious neurological consequences. In the worst case, the inability to restart the pump can provoke a fatal outcome. All products in three high-risk groups are manufactured by the same supplier, whose name is not disclosed. At the same time, pumps for which an increased probability of failure has not been established were manufactured by another company. The U.S. Food and Drug Administration (FDA) has released a notice advising high-risk patients to contact their health care provider.[1]
2022
Medtronic reported a defect in the controller drive mechanism associated with the cover
In early December 2022, Medtronic issued an urgent notice to correct the situation with medical equipment due to potential problems related to the HeartWare HVAD device.
The notification alerts healthcare professionals to the safety associated with the actuator cover of the HeartWare Ventricle Assist Heart Device (HVAD). Over time, the spindle lid can harden. This may make it difficult or impossible to slide the cover back to access the transmission controller connector.
Delaying access to the connector can result in injury to the patient as a result of a prolonged pump stop, Medtronic said in a notice. The company attributes this problem to the loss of a plasticizer that environmental factors can accelerate. The plasticizer makes the transmission cover material soft and pliable.
Between January 3, 2017 and September 15, 2022, Medtronic received 33 complaints about a hardened or stuck gimbal cover. In the observed complaints, the problem arose after several years of use. In all 33 cases, users reported that the transmission cover was difficult to remove or impossible to manually manipulate.
In 25 of the 33 cases, users reported little or no harm to the patient. Four patients who experienced a hardened gimbal closure were hospitalized for unrelated reasons. In the remaining four cases, the observation of a hardened cardan transmission cap was caused by a routine clinic visit. These patients were hospitalized for maintenance and removal of the cardan cover. Medtronic did not link these cases to critical injuries or possible patient deaths.[2]
Medtronic recorded dying from its defective heart pumps
In late August 2022, Medtronic reported six more injuries and one death related to battery problems powering the HeartWare Ventricular Assist Device. It comes after the recall of 429 batteries due to a welding problem that led to two injuries and one death.
The company pulled the heart pump from sale in 2021, after Ministry of Health USA information receiving more than 3,000 deaths related to various problems with the device, according to published reports.
As of August 2022, Medtronic received 1,159 complaints related to battery electrical malfunctions, including five reports that both batteries either failed or disconnected from the controller, MedTech Dive said in an email. External batteries provide power to a pump implanted in the chest to provide mechanical support to the failing heart. The company took the HeartWare Ventricular Assist Device (HVAD) system off the market in 2021, but since then there have been several recalls of Class I devices.
The company began recalling more than 23 thousand batteries after the developers discovered electrical malfunctions, due to which the batteries could not supply power to the system control device or receive a charge, or it seemed that they remained charged, but were discharged. Medtronic pointed to the interaction between the battery software configuration and the battery printed circuit board, which can cause electrical malfunctions in some batteries.
Medtronic confirmed the last two deaths in an email to Medtechdive, but would not comment on the total number of reported deaths related to the HVAD system. The developers asked doctors to check components during clinic visits and replace damaged or worn-out AC adapters, DC adapters, batteries and alarm adapters.[3]
Recall defective heart pumps
On June 23, 2022, Medtronic recalls defective heart pumps HeartWare Ventricular Assist Device, which have batteries that do not hold a charge well. This is the second Grade I recall for this month.
The Class I recall relates to a potential welding defect affecting a specific batch of external batteries for the HeartWare Ventricular Assist Device (HVAD). Medtronic became aware of complaints that the batteries stopped supplying power or did not hold a charge. The company began to seize the affected batch of batteries and replace them.
Medtronic reported one fatality related to the latest recall and two complaints about the affected shipment, according to the Food and Drug Administration (FDA). The FDA reported that 429 batteries produced from April 13, 2021 to April 19, 2021 and distributed from April 20 to July 19, 2021 fell under the recall.
 | The well-being and experience of patients implanted with the HVAD pump is vital to us. Although Medtronic no longer distributes the HVAD system, we continue to assess the quality and control measures to improve patient safety and therapy effectiveness, said Medtronic researcher Erika Winkels. |  |
The HVAD system is an auxiliary ventricular device used in end-stage heart failure patients awaiting a heart transplant. The system from Medtronic can also be used in patients with end-stage heart failure who are not suitable or too ill for a heart transplant, and whose symptoms do not respond to medical treatment. This use is known as targeted therapy, which can prolong a patient's life and improve their quality of life.[4]
2021: Heart pump sales close after string of defective product recalls
In early June 2021, Medtronic announced it was discontinuing sales of its HeartWare Ventricular Assist Device (HVAD) heart pumps following a string of reviews of defective products. The company has notified customers of the need to switch to alternative mechanical circulatory support.
Medtronic is also developing a program to support patients who have had HVAD implanted to provide them with ongoing care and safety. There seemed to be about 4,000 such patients.
An increasing number of observational clinical studies show that the use of the Medtronic HVAD system has a higher frequency of neurological adverse events and a higher mortality rate than other commercially available devices. In addition, the regulatory authorities regularly received complaints about the delay or inability to restart the implanted heart pump.
Medtronic said the decision to stop selling was made in light of several clinical studies revealing a high incidence of neurological complications, including stroke and death. In February, Medtronic reported 12 deaths among patients with implanted pumps, though three were not linked to HVAD problems.
In response to the withdrawal of Medtronic devices from the market, Abbott issued a statement confirming that the company will be able to sustain the growing demand for mechanical circulatory support devices by boosting production of its HeartMate 3 heart pumps. Abbott also said it was organizing additional training programs for cardiac surgeons.
Analysts acknowledged that the situation is unfavorable for Medtronic, but they do not expect a significant negative impact on the development of the company and its financial performance.[5]
2020
Medtronic recalls defective circulatory aids after deaths
At the end of May 2020, Medtronic began recalling defective HeartWare HVAD ventricular bypass devices. The recall belongs to class I, that is, the problem poses a threat to the lives of patients and has already led to four deaths.
According to the regulator report, due to a defect in production, the output department of the HVAD apparatus may break, and the tension unloading screw may break during assembly even before implantation, but the defect may not be noticed even after pre-implantation assembly and attachment of these parts to the HVAD pump.
Medtronic reported that the use of these devices can cause serious harm to the patient and lead to death. Among the complications are such as dizziness, loss of consciousness, bleeding and fluid accumulation in the heart bag. The patient may also require additional medical procedures.
At the end of May, Medtronic received 92 complaints related to the device. Medtronic reported four device-related deaths, including two cases involving rupture of the apparatus's exit section and two cases involving subsequent complications following additional intervention.
Medtronic sent out a warning to all affected customers. The company recommends checking all the assembly steps of the device listed in the appendix to the device and carefully examining the graft after assembly and before implantation. In the event of complications, the company recommends following the standard perioperative and immediate postoperative management of the patient.
The recall affects devices that were distributed on the market from March 1, 2018 to April 1, 2020. In total, 4924 devices are subject to recall.[6]
Medtronic warned of a serious marriage in its heart pumps
In mid-April 2020, Medtronic published a safety notice in Europe that concerns the serious defect of manufactured heart pumps. The company warned that during pre-implantation procedures, the HeartWare HVAD system could fail.
It turned out that one of the elements of the HeartWare HVAD heart pump is susceptible to breaks, and the tension relief screw can break during assembly of the pre-implantation pump and attachment to the HVAD pump.
Medtronic has proposed additional build and mount steps that are designed to reduce the risk of rupture and damage. In the case of patients who have already had an HVAD heart pump implanted, no action is required as the damage occurs only during graft assembly.
By early March 2020, the company had received 92 complaints related to the issue after selling nearly 22,000 HVAD heart pumps. In total, Medtronic reported two deaths directly related to the defective apparatus and two deaths related to subsequent complications after the intervention.
Medtronic received 54 complaints about a broken heart pump part that resulted in perioperative and postoperative bleeding, as well as 38 complaints about broken tension relief screws, but the issue did not directly harm patients. Product damage was detected before or during implantation in 74 cases and after implantation in 18 cases.
The company said it was working with regulators to redesign the pump to reduce the risk of damage associated with these issues. In addition, Medtronic will train specialists about the new modification. Users are urged to carefully inspect the heart pump after assembly and before implantation.[7]
Medtronic recalls defective heart pumps after patient dies
In mid-March 2020, Medtronic recalls defective HeartWare HVAD ventricular accessory circulatory machines following the patient's death. Almost 5500 devices are subject to recall.
HeartWare HVAD heart pumps help the affected left ventricle pump blood, such as in patients with end-stage heart failure. The system consists of an implantable pump and a controller that controls the pump from the outside. However, it turned out that the design of the device creates the ability to insert the charger adapter into the wrong port, causing damage that requires replacing the controller.
Medtronic received 36 complaints on the issue by mid-January 2020. In one case, the need to replace the controller caused complications that led to the death of the patient. Regulatory authorities did not provide updated adverse event data in their notification.
| | Controller replacement can lead to pump shutdown, exacerbation of symptoms of heart failure and/or symptoms associated with hypoperfusion, i.e. weakness and dizziness, anxiety, nausea, loss of consciousness, or even death. The severity of the harm caused depends on the state of the patient's cardiovascular system, Medtronic explained. | |
Medtronic has also released materials designed to reduce the risk of malfunction. Company representatives advise medical professionals to carefully follow the recommendations for connecting a power source. If the patient hears constant unpleasant noise from the device, he should immediately consult a doctor for instructions.
The company also warns users that only attached adapters can be inserted into the controller, and the use of other cables can damage the device and replace it.[8]
2018: Repeat recall due to conductor issues
On June 4, 2018, Medtronic announced another recall from the HeartWare HVAD heart pump market, which the company acquired in 2016. The identified problem was assigned the highest hazard status, but the risk of a defect is relatively low.
According to the manufacturer's statement, when using an HVAD device, the electrical connection between the device's power source (battery, AC adapter, or DC adapter) and the controller may be interrupted. This can cause the device to switch to a secondary power supply; Note here that said device beeps fault signal. Medtronic said the problem was caused by the oxidation of connecting surfaces between the power supply connector and the controller socket; the signal interruption usually does not exceed 2 seconds.
Medtronic suspects that the defect may occur in 204,017 HeartWare devices. Patients are advised to connect HVAD to two power supplies. While there is little chance of signal disruption, such a defect can cause the pump to stop, exacerbating a patient's symptoms of heart failure or can cause weakness, dizziness, anxiety, nausea, loss of consciousness and even death. Patients with terminal heart failure and patients who are completely dependent on the HVAD system are most at risk.
Medtronic drew the attention of doctors to the fact that it continues to improve the HVAD system to reduce the risk of unintentional switching of the power source. The company said it has already identified a risk mitigation plan for patients with established HVAD and intends to put them into production until regulators re-audit.[9]
2016: Recall of defective devices
At the end of September 2016, Medtronic announced the recall of heart pumps developed by HeartWare, which the American medical device giant had previously acquired for $1 billion. A defect in the device can lead to deaths.
According to Bloomberg, citing Medtronic spokesman Chris Garland, the problem with the HVAD System is moisture entering the mechanical pump through power connectors or data transmission. Because of this, one patient could die, Garland said.
Medtronic said that as of the end of September 2016, nearly all of the 8,799 patients who may be affected by a malfunction in the HVAD System are informed. In addition, the manufacturer replaced controllers in 308 devices.
Although the recall campaign for the HVAD System was publicly announced in September, already in May-June, doctors and patients began to receive messages from the manufacturer with recommendations for closely monitoring the operation of the device with weakened connections.
The U.S. Food and Drug Administration (U. S. Food and Drug Administration) has awarded this recall the first class, which means that the problem in the product can become a threat to life.
In August 2016, Medtronic recalled heart pump kits from hospitals due to the risk of a short circuit and connection problems when moisture enters. Then the company updated 323 of 350 potentially dangerous devices.[10]
Notes
- ↑ Medtronic identifies patients at increased risk of heart pump failure
- ↑ Medtronic warns on HeartWare HVAD again
- ↑ Medtronic reports six more injuries, one additional death related to HVAD battery problems
- ↑ Another Medtronic HVAD recall is serious
- ↑ Medtronic stops sales of its HVAD system
- ↑ Four deaths linked to Medtronic HeartWare recall
- ↑ Medtronic field safety notice in Europe involves potentially serious HVAD problem
- ↑ FDA issues Class I recall for Medtronic's HeartWare HVAD after patient death
- ↑ Medtronic Recalls HeartWare VADs Again Due to an Electrical Problem
- ↑ Medtronic Heart Pump Recall Deemed Life-Threatening by FDA
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