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

Device Problem Insufficient Information (3190)

Patient Problem Prolapse (2475)

Event Date 08/26/2008

Event Type  Injury  

Event Description

It was reported to gore that a patient underwent abdominal sacrocolpopexy for vaginal vault prolapse.

Manufacturer Narrative

Medical records dated (b)(6) 2000 describe the use of gore-tex suture during the abdominal sacrocolpopexy procedure as follows: "the graft was then cut the appropriate length and sewed approximately 4 cm underneath the cystocele component onto the vagina with several interrupted sutures, the uterosacral ligaments were individually plicated with gore-tex suture incorporating the entire length of approximately 3-4 cm length of the uterosacral ligament and approximating this to both posterior vagina as well as sleeve of the graft.With completion of these sutures as well as the other gore-tex sutures onto the graft the cul-de-sac was obliterated completely.The graft was then reapproximated with sacral promontory with two interrupted sutures under direct visualization of the presacral blood." medical records dated (b)(6) 2008 describe: ¿irregular spotting suture protruding through apex now ¿ removed with excision.¿ the instructions for use addresses the potential for following adverse reactions among others: "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.".

• Brand Name: GORE-TEX® SUTURE
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: natalie putnam ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4703431
• MDR Text Key: 5718398
• Report Number: 2017233-2015-00239
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P820083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/18/2015

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 74