SynCardia Systems Failed to Submit MDRs for Patient Deaths, FDA Says

Tucson, Az.-based SynCardia Systems drew an FDA Form 483 for failing to submit MDRs on adverse event reports for about 70 deaths linked to the use of its device intended to help patients recover after undergoing surgery for artificial heart implants.

A four-day August inspection at the device manufacturing facility revealed it had received information between April 2014 and March 2017 about the deaths of patients who used its Companion 2 Driver System, but it did not submit any MDRs to the agency.

The firm was also cited for having inadequate procedures for device design changes. An FDA investigator reviewed the design history files for its Companion 2 Driver and its Freedom Driver System, and observed that pre and post PMA design changes were “neither included nor referenced in the documents.”