WASHINGTON, D.C. — The U.S. Food and Drug Administration, the agency in charge of permitting medical device manufacturers to market medical devices announced a Class 1 recall for Edwards Lifesciences’ SAPIEN 3 transcatheter device. The SAPIEN 3 is used during aortic transcatheter heart valve procedures. Hitinfrastructure.com reported that one person died, and 17 other people sustained injuries when the balloon deflated and made retracting the device extremely dangerous for the patient. The FDA continues to allow physicians to use the device provided that they follow highly specific protocols if the balloon breaks despite characterizing the recall as worthy of a Class 1 designation. A Class 1 recall is the most acute warning level of recall used by the agency. The FDA defines recalls as Class 1 when the defect has the potential to cause serious injuries or death to the patient.
The recalled transcatheter system has been used by physicians in the U.S. since early January of 2019. Despite 17 injuries and one death, the FDA allows doctors to use the device. Edwards Lifesciences offered physicians extensive and detailed instructions on how to prevent injury and death if the balloon breaks. Edwards Lifesciences says that doctors must inflate the balloon slowly and use a minimal amount of inflation. Otherwise, the potential for the balloon to rupture greatly increases.
Patients have been injured or died after the balloon burst. If the balloon breaks, doctors will have a very difficult time trying to retract the balloon back into the device. The aortic valve and other arteries could rupture or tear if doctors are unable to remove the balloon successfully. Patients run the risk of suffering torn or cut vascular bodies, which could cause massive bleeding and require additional surgical procedures to repair.
Health Canada announced a recall for the device as well. There was no information available about how many people in Canada were hurt or died from the faulty medical device.
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