Abiomed Responds to MedSun Report on Two Impella Pumps

Editor's note: This story has been updated from the original story to include comments from Abiomed. A report published through FDA's medical product safety network (MedSun) database describes two issues that involve Abiomed's Impella heart pumps. However, the company told MD+DI that the information in the MedSun report is inaccurate. According to the report, which is located here on FDA's website, one Impella pump reportedly had an unknown "material" inside the pump, causing it to have flows "less than expected," and another pump's housing/outlet cage and impeller were somehow crushed and the device did not start. Abiomed claims that the pumps did not malfunction. "The first pump worked exactly as it was supposed to – a clot was detected in the patient’s bloodstream and a safety mechanism triggered, shutting down the pump, so the clot did not go to the patient’s brain.  The second pump was damaged during the insertion process," said Tom Langford, director of communications and public relations at Abiomed. MedSun is an adverse event reporting program launched in 2002 by FDA's Center for Devices and Radiological Health (CDRH). The way the program works is participants use an Internet-based system that is designed to serve as an easy and secure way to report adverse medical device events. The agency says the primary goal for MedSun is to work collaboratively with th...
Source: MDDI - Category: Medical Devices Authors: Tags: Implants Source Type: news