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

Model Number	0N05A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Fluid Discharge (2686); Foreign Body In Patient (2687)
Date of Event	11/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per the gore-tex® suture instructions for use (ifu), possible adverse reactions associated with the use of any suture include, but are not limited to, tissue dehiscence, infection, localized inflammatory reaction, and transitory local irritation.Broken needles or damaged thread may result in extended or additional surgery or retained foreign bodies.A review of the associated manufacturing and sterilization records indicated that suture lot 21269777 was manufactured according to approved procedures and met all release specifications.
Event or Problem Description
The following was reported to gore: on (b)(6) 2019, during the procedure of rhinoplasty, physician a used a gore-tex® suture to suture on the patient¿s nose and forehead.After the procedure, the patient found there was unknown fluid flowed from the nose and told to physician (b)(6).Physician (b)(6) applied some medicine to the patient and confirmed that patient's symptoms were fine.However, the patient's symptoms didn't improve and were even worsened, not only the affected area became more painful, but also the nose was atrophy.On (b)(6) 2020, the patient went to hospital for review.And on (b)(6) 2020, physician (b)(6) from other hospital performed foreign body and gore-tex® suture removal, and repaired of septal perforation by mucosal flap.The suture was broken when physician (b)(6) cut it for removing.After this operation, the patient's pain was relieved slightly.However, the patient's nose has been deformed due to muscle atrophy.Before this operation, the patient went to another clinic for consultation.It was diagnosed that the patient was suffering from infection of the nose tissue.This infection was suspiciously caused by physician a's procedure off-label use and the suture not completely disinfected.

• Brand Name: GORE-TEX SUTURE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10639589
• Report Number: 3003910212-2020-01108
• Device Sequence Number: 3650050
• Product Code: GAW
• UDI-Device Identifier: 00733132600106
• UDI-Public: 00733132600106
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P820083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: 0N05A
• Device Catalogue Number: 0N05A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 48 YR
• Patient Weight: 47