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

Catalog Number SBT1602D

Device Problem Insufficient Information (3190)

Patient Problems Ischemia (1942); Thrombosis (2100); Fungal Infection (2419)

Event Date 11/27/2013

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.(b)(4).Further investigation is being conducted and the information will be included in the final report.

Event Description

The patient presented with a critical ischemia on the left limb where a gore-tex® bifurcated vascular graft was implanted as an aortobifemoral bypass on (b)(6) 2013.Following the operation, candida albicans infection was treated medically.In (b)(6) 2016, the right leg of the bypass presented a thrombosis which was surgically thrombectomyzed.Also the contralateral leg indicated a thrombosis and the presence of a periprosthetic mass was observed.Therefore, a thrombectomy of the left side of the gore-tex® bifurcated vascular graft was performed and a new bypass, with a pet prosthesis, between the left profunda femoris artery and the left common femoral artery, was sutured to the preexisting aortobifemoral bypass on (b)(6) 2016.On (b)(6) 2016, after about 3 years, the prosthesis was explanted due to a candida albicans infection.The patient was implanted with a new aorto-bifemoral bypass (allograft) and is doing well following the procedure.

Manufacturer Narrative

(b)(4).The review of the sterilization records verified that this lot met all pre-release specifications.(b)(4).The gore-tex® bifurcated vascular graft was returned to (b)(4), independent laboratory, for investigation.Submitted in formalin was a bifurcated gore-tex® stretch vascular graft: two fragments, one trunk fragment (segment 1) with a non-gore pet graft attached at the distal end and one leg fragment (segment 2).The scope and results of the investigation were summarized and a report was submitted to w.L.Gore & associates.An explant investigator (ei) at w.L.Gore & associates reviewed the report.The following is a summary of the ei observations: tissue present: yes.Graft fragments have multifocal areas of light tan to yellow fibrous tissue adhered to the albumen and appears to have a portion of native vessel attached to the proximal trunk.Luminal tissue deposition cannot be determined via mode of analysis.From gross images segment 1 has one leg transected approximately 2cm distal to the bifurcation and the remaining leg is anastomosed (blue suture) to the pet graft.White suture fragments are present within the proximal trunk and attached vessel which is likely the aortic anastomosis.Segment 2 has been transected at both poles (one strait, one angled).One blue suture fragment is present at the angle cut pole.Metal surgical instruments were used during the evaluation of the returned specimen, as is evident from the photographs in the report.Request for additional analysis: no.Reason: material disruptions are consistent with surgical instruments used during the explant process.Based on review of the report in conjunction with the conclusion of the (b)(4) investigators, no additional analysis is requested.

• Brand Name: BIFURCATED GORE-TEX® STRETCH VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6408779
• MDR Text Key: 70061081
• Report Number: 2017233-2017-00128
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K904282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2017

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: 11/27/2017
• Device Catalogue Number: SBT1602D
• Device Lot Number: 10852071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2012
• 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: 95