Such a heart valve made by Medtronic called CoreValve amassed the most reports, with more than 5,800 death incidents reported since 2014, according to Medtronic. The device was initially approved for patients too sick for open-heart surgery.
The device helped boost survival in fragile, elderly heart patients, with nearly three-quarters still alive and free of major strokes a year after the valve was implanted. It and a competing, similar valve have since been approved for use in younger, healthier patients.
The quarterly summary reports filed with the FDA note hundreds of deaths and thousands of injuries. They say the “anonymized” registry data did not have enough information for Medtronic to determine whether the event was previously reported to the company or the FDA’s public device-injury database called MAUDE. The spreadsheet sent straight to the FDA includes “observations related to patient deaths.”
Medtronic filed far fewer stand-alone public device-death reports, about 900, many summarizing valve-related deaths mentioned in published research. While device companies are required to report patient deaths to the FDA if they have enough information to investigate, doctors are not ― explaining some of the reporting gap.
Medtronic said in a statement that it strives to eliminate malfunctions in all of its devices, but, when they occur, “we make every effort to inform regulators, the healthcare community and the public in a timely … manner.” The company said about 40% of deaths reported from the registry data list no cause, so it’s unclear if they were related to the device.
