MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE-TEX® SUTURE CV4; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	4U06B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the gore-tex® suture instructions for use precautions, when tying knots with the gore-tex® suture, tension should be applied by pulling each strand of the suture in opposite directions with equal force.As the knot is tensioned, the air in the suture is forced out.Care should be taken to avoid using a jerking motion which could break the suture.
Event or Problem Description
It was reported to gore that during an abdominal aortic aneurysm resection, a gore-tex® suture was used to suture a gore-tex® vascular graft to the root of the middle artery vessels.However the suture was reportedly broken during knot tying.Then the physician used the remaining suture to tie the knot to complete the procedure.There was no injury to the patient.

• Brand Name: GORE-TEX® SUTURE CV4
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8456085
• Report Number: 3003910212-2019-00050
• Device Sequence Number: 429700
• Product Code: GAW
• UDI-Device Identifier: 00733132603121
• UDI-Public: 00733132603121
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P820083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 4U06B
• Device Lot Number: 14643188B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 56