FDA EIR - Thoratec LLC - October 09, 2020

An FDA post-market inspection of Thoratec Corp., now part of Abbott Laboratories, Inc., took place from October 6-9, 2020, at its Pleasanton, CA facility. The inspection was conducted under established compliance programs for post-market medical device inspections, focusing on the Class III HeartMate 3 Left Ventricular Assist System (P160054) and its pre-market approval commitments, including Medical Device Reporting and Unique Device Identifier requirements.

The inspection concluded without the issuance of a Form FDA 483, indicating no formal objectionable conditions were observed. However, a significant discussion item involved the submission schedule for annual post-market approval reports. It was noted that the 2nd and 3rd annual reports deviated from the required submission interval of one year from the original PMA approval date (August 23, 2017), and the 1st report was also slightly curtailed. Management committed to rectifying this discrepancy.

Key areas reviewed included the Corrective and Preventive Action (CAPA) system, internal audits, and complaint processing. An ongoing CAPA (114896) related to outflow graft twists, which had previously led to a Class I recall (Z1774-2018), was examined. While this issue was in its effectiveness verification phase, the inspection found no issues with the firm's procedures or management of this CAPA. No samples were collected, and no refusals were encountered, resulting in a "No Action Indicated" classification for the inspection.