MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE TEX® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Catalog Number ST6L

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Fistula (1862); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994)

Event Date 11/03/2006

Event Type  Injury  

Event Description

It was reported to gore that a patient alleges to have experienced infections, pain, incontinence, fistulas, inflammation, and abscess after having been implanted with a gore-tex vascular graft in the vaginal area.Reason for implant was cystocele.

Manufacturer Narrative

Review of device manufacturing record history confirmed device met pre-release specifications.Ifu indications for use states the following: gore-tex vascular grafts are intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

Event Description

On (b)(6) 1998, patient presented with cystocele and stress incontinence.Anterior repair and pereyra procedure with cystoscopy was performed.A gore-tex vascular graft was implanted in the vaginal mucosa.On (b)(6) 2006, it was noted that no foreign bodies or fistula was observed during cystoscopy.On (b)(6) 2006, two prolene sutures were found and removed during the suprapubic exploration and cystoscopy of bladder.During a cystoscopy on (b)(6) 2006, a gore-tex material was found that was implanted during a urethropexy performed years ago.Operative report dated (b)(6) 2006 states that patient presented with a recurrent pelvic abscess.Upon dissection, a granulomatous-type inflammatory tract was found and carried down to about 1cm of the gore-tex graft bolster.The tract was removed and debridement was done above and below the fascia.The wound was irrigated with kantrex antibiotic solution.A drain was placed.No complications were noted.

Manufacturer Narrative

The sterilization records for lot# 495282 are unavailable for review.Based on a manufacture date of 10/18/1995, the required record retention period of 10 years have been exceeded.Although documents are unavailable, standard manufacturing procedures require lot history review before release of the sterilization batch to ensure compliance with device specifications.

• Brand Name: GORE TEX® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: genevieve begay ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3814222
• MDR Text Key: 17931658
• Report Number: 2017233-2014-00255
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2015

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
• Device Expiration Date: 10/18/2000
• Device Catalogue Number: ST6L
• Device Lot Number: 495282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/29/2014; 10/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/1995
• 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): Other
• Patient Age: 74 YR
• Patient Weight: 70