Synovis Chided for Inadequate CAPA Following Device Failure
The FDA hit Baxter’s Synovis unit with a Form 483 for not initiating corrective and preventive actions for nonconformities to its Terminally Sterilized Vascu-Guard patch.
Specifically, between March 30 and April 10, the company identified potential nonconformities for the product and failure mode through its complaint handling system. The FDA made this determination during a May 26 to June 17 inspection of the St. Paul, Minn., facility. “Users were unable to determine the rough vs. smooth side of the Terminally Sterilized Vascu-Guard patch, as both appeared to be rough,” according to the 483. Several users declined to use the patch, which is intended for peripheral vascular reconstruction.
Moreover, the product’s instructions for use states that implanting the rough side toward the vascular surface could “cause permanent impairment or life threatening injury, which is a critical failure,” according to the 483.
Synovis addressed complaints through an FAQ document circulated by sales reps, and initiated risk-assessment activities internally following complaints, but did not do so within the CAPA system, the 483 notes.
Also, the firm didn’t evaluate and investigate the failure of the device to meet its specifications, and didn’t evaluate and escalate investigations when the complaint rate exceeded the expected occurrence rate, the FDA says. Finally, the 483 cites Synovis for design validation deficiencies for not ensuring the device conforms to defined user needs.
Earlier this summer, Baxter reported a recall of four product codes of the patch after the same problem was reported. At the time, the company said it had received and was investigating a few adverse event reports involving the products, among them postoperative thrombosis and stroke ().