Obsidio Conformable Embolic

2024

More people die from defective Boston Scientific vascular devices

In mid-October 2024, the U.S. Food and Drug Administration (FDA) released a new notice regarding Boston Scientific's defective Obsidio Conformable Embolic vascular devices . Using this pre-mixed embolic agent to block or occlude blood flow to certain blood vessels continues to take people's lives.

The recall of Obsidio Conformable Embolic products, initiated in early 2024, according to the FDA classification is type I - the most serious. This means that the use of the product can lead to serious injury or death of patients. As of April 2024, two deaths were reported. By the end of October of this year, two more people died due to the use of Obsidio Conformable Embolic. In addition, it is said that eight more patients were harmed by health (not counting seven victims earlier).

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bostonscientific.com

At the same time, Boston Scientific has updated the instructions for the use of Obsidio Conformable Embolic devices. It is said that there are risks when using products in any area of ​ ​ the gastrointestinal tract (GI), and not only in the lower parts, as previously assumed.

While Boston Scientific believes Obsidio Conformable Embolic has advantages over competing products such as liquid embolizing agents, some doctors ran into trouble when they started using vascular devices after their FDA approval in 2022. The notification of the department notes that the risks associated with the product can lead to non-targeted embolization and a decrease in the flow of blood and oxygen to the organs, and also "can provoke long-term hospitalization."^[1]

Recall of defective devices

On April 17, 2024, the US Food and Drug Administration (FDA) announced the recall of Obsidio Conformable Embolic products supplied by Boston Scientific. The use of defective devices can result in severe harm to the health of patients or even provoke death.

Obsidio Conformable Embolic is a pre-mixed embolic agent that is delivered in a minimally invasive way through a catheter system to block or occlude blood flow to certain blood vessels. After injection, a solid formation is formed in the vessel, due to which the blood flow stops. device is intended for single application for embolization of hypervascular tumors and occlusion of blood flow in bleeding and/or hemorrhaging peripheral blood vessels.

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Boston Scientific

It turned out that the use of Obsidio Conformable Embolic in the embolization of bleeding in the lower gastrointestinal tract (GI) creates a high risk of intestinal ischemia. The use of this product can prevent blood and oxygen flow to organs, including the small intestine, or create non-target embolization. This can provoke the need to perform major surgery, such as resection of the intestines. As a result, the patient may require prolonged hospitalization.

As of April 2024, 11 incidents related to the described problem are known. In seven cases, the health of patients was harmed, while two people died. Products supplied from May 8, 2023 to February 8, 2024 are subject to recall. In total, according to the FDA notice, approximately 1,600 defective devices entered the market.^[2]

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