(KFF Health News) – The men’s deaths are among more than 4,500 reports since August 2017 in which the HeartMate 3 may have caused or contributed to a patient’s death, according to a KFF Health News analysis of the FDA’s database of medical device incidents, known as the Manufacturer and User Facility Device Experience, or MAUDE. Hospitals, doctors, and others report device-related deaths, serious injuries, and malfunctions to manufacturers, who are required to investigate and report cases to the FDA.

In nearly 90% of those 4,500-plus reports, Thoratec said it found no problem with the device or how it was used, according to a KFF Health News review of the FDA database. (Read More)