MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX STRETCH VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Catalog Number SAX01

Device Problem Contamination (1120)

Patient Problem Fungal Infection (2419)

Event Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer: the medical device returned to a third party for investigation.The analysis report was shared with gore and evaluated appropriately.The investigation is still ongoing.The results will be included in the final report.

Event Description

It was reported to gore that patient underwent endovascular treatment for an axillo-bi-fémoral bypass with a gore-tex® stretch vascular graft - standard-walled axillobifemoral removable ringed.It was stated that the prosthesis was implanted on (b)(6) 2007 in order to treat a critical ischemia due to aortic occlusion following abdominal radiation.It was reported that on (b)(6) 2020, after about 13 years, the prosthesis was explanted due to infection to candida candida albicans.A part of the explanted prosthesis was sent for analysis.

Manufacturer Narrative

H6 evaluation codes investigation findings 213 refers to the phr-review.Phr-review: a review of the manufacturing records indicated the lot met all pre-release specifications.A review of the sterilization records indicated the lot met all pre-release specifications.Explant investigation (ei): the following is a summary of the ei observations: tissue present: yes minimal, scattered plaques of red/brown, tan, and yellow tissue were present on the abluminal surfaces.Material.The luminal views of vgf-1 were occupied with white/yellow and dark red tissue.The luminal views of vgf-2 showed small, scattered foci of tan/brown tissue.However, the luminal patency of both fragments could not be determined from the images/information provided.Vgf-1: extremity a was transected and presented in a broken ovular shape with multiple fragments of blue suture present.A transparent, plastic-like piece of material with underlying white suture was observed at extremity a, which was consistent with a portion of the manufactured bifurcation.The fragment was transected at extremity b with a partial circumferential transection present near extremity b.Extremity b was covered in white/yellow and dark red tissue, with one blue suture fragment being visible in the tissue.Most of the rings on the fragment had either been removed or disrupted.Evenly spaced serration marks were present on one leg, causing the fragment to be partially flattened.It cannot be determined if the extremities corresponded to an anastomotic site, an area marked for orientation with suture, or an in-vivo intervention area with the images/information provided.Vgf-2: a tag of tan/yellow tissue was present, extending from the abluminal surface in the mid-region of the graft.The fragment was transected at both extremities; both presented ovular in shape.Evenly spaced serration marks were present on the fragment.Most of the rings on the fragment had either been removed or disrupted.A partial longitudinal transection with blue running suture repairing it was present near extremity b.Material disruptions (i.E., transections, missing/disrupted rings, serration marks/flattening, blue suture) are consistent with those caused by surgical instrumentation (i.E., scalpel/scissors, forceps/clamps, suturing) likely used during a surgical procedure.Request for additional analysis: no reason: based on the ei¿s review of the third party report and reason for removal (infection), no additional analysis is requested.

• Brand Name: GORE-TEX STRETCH VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10868440
• MDR Text Key: 217134895
• Report Number: 2017233-2020-01466
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K901641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

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: 07/11/2012
• Device Catalogue Number: SAX01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 08/06/2021
• Supplement Dates FDA Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR