| Developers: | Abiomed |
| Branches: | Pharmaceuticals, Medicine, Healthcare |
Content |
2023
Pump recall due to instruction errors
On August 17, 2023, the U.S. Food and Drug Administration (FDA) announced a new recall of heart pumps to Abiomed, part of Johnson & Johnson. Impella RP Flex with SmartAssist products fell under the program, the use of which can result in harm to the health of patients.
The named pump is intended for patients with acute right ventricular heart failure after implantation of an auxiliary device for the left ventricle, myocardial infarction, heart transplantation or open heart surgery. The article is implanted transdermally with a flexible cannula through the internal jugular vein. The system provides patient mobility, and therapy can be carried out up to 14 days.
The recall is because the Impella RP Flex with SmartAssist Heart Pump Operating Manual does not properly specify the precautions that health care providers should take into account when treating. We are talking primarily about patients who are prescribed anticoagulant therapy. Non-compliance with safety measures could lead to serious adverse health effects, including the risk of blood clots, the notice said. In the worst case, therapy can result in the death of the patient.
The recall includes Impella RP Flex with SmartAssist products with model number 1000323, which were delivered to the market between November 1, 2022 and August 2023. Abiomed has received 12 reports of harm to the health of people receiving therapy using these pumps. No deaths were recorded. The manufacturer said it will make changes to the operating instructions explaining the risk factors associated with the possibility of blood clots.[1]
Pump recall due to defect
On June 5, 2023, the U.S. Food and Drug Administration (FDA) announced the recall of heart pumps to Abiomed, part of Johnson & Johnson. The use of these devices creates significant risks to the health and life of patients.
We are talking about Impella 5.5 with SmartAssist devices. This heart pump is designed to provide cardiac support for a long time while maintaining patient mobility. The solution optimizes patient recovery by using intelligent, real-time algorithms.
It is reported that in these cardiac devices, flushing fluid may leak from the side branch of the pump. If this happens, low pressure will be observed in the system. The result could be a full pump stop and discontinuation of therapy. In patients who are already in serious condition, a malfunction of the device can provoke a sharp deterioration in health and even death. Abiomed has registered at least 179 complaints about the operation of the system. Three patients experienced complications, but no deaths were reported.
The notice, published on the FDA website, states that copies of Impella 5.5 with SmartAssist with product code 0550-0008 are subject to recall. These heart pumps were delivered to the market from September 28, 2021 to March 6, 2023. In total, the defect affects 466 devices. The manufacturer urges against the use of problematic equipment and contact support to determine the return date. According to the FDA classification, the recall corresponds to category I (Class I), which indicates the maximum level of danger for patients.[2]
2022: Heart pump problems
On December 5, 2022, the Food and Drug Administration (FDA) announced that the agency was updating Abiomed's Impella RP system labeling to reflect the results of the final study.
Abiomed announced in October 2022 that the FDA had approved the Impella RP Flex system with the SmartAssist system delivered by the catheter. It is a system from Abiomed providing temporary support to the right ventricle of the heart for up to 14 days. After implantation of a left ventricular accessory device, myocardial infarction, heart transplant, or open heart surgery, people may develop acute right ventricular heart failure or decompensation.
In December 2022, the FDA updated the Impella RP system labeling: the system is indicated to provide temporary right ventricular support for up to 14 days in patients with a body surface area of ≥1,5 square meters. Who develop acute right ventricular heart failure or decompensation during. Less than 48 hours after implantation of a left ventricular accessory device, myocardial infarction, heart transplant, or open heart surgery, without the presence of deep shock, end organ failure, or acute neurological injury.
According to the FDA, patients in the post-approval study who met the criteria for enrollment in pre-market clinical trials showed similar survival rates. The agency reported that 23 of the 33 patients (69.7%) to be evaluated survived to 30 days after the device was explanted or discharged from the hospital or before the next longer therapy began.
However, among those who would not have undergone a pre-market study, survival was much lower than 18.6%, or 13 of the 70 patients assessed. Patients who would not have entered the study were more likely to be in a state of acute right-sided heart failure or decompensation for more than 48 hours. In addition, they may have experienced severe cardiogenic shock, end organ failure, or acute neurological injury.
As a result, the FDA updated and tightened the labeling indications. The authority said it would continue to work with Abiomed to monitor reports of adverse events and inform health care providers.[3]
Notes
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