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

Model Number S0607

Device Problem Contamination (1120)

Patient Problem Bacterial Infection (1735)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

Analysis report was received from third party and will be further investigated.A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.

Event Description

It was reported to gore that the patient underwent surgical treatment to create an access for hemodialysis with a gore-tex® stretch vascular graft ¿ standard-walled.It was stated that the vascular graft was implanted on (b)(6) 2021.It was reported that on (b)(6) 2021, after about 4 months, the vascular graft was explanted due to infection with staphylococcus aureus méti-r.A segment of the graft was sent for analysis.

Manufacturer Narrative

Explant investigation: the device was returned to geprovas for investigation.Submitted in formalin was a gore-tex® stretch vascular graft fragment.The scope and results of the investigation were summarized, and a report was submitted to w.L.Gore & associates.An explant scientist at w.L.Gore & associates reviewed the report.Explant scientist observations: the graft fragment was reported to measure 15 mm in length with both ends transected and the fragment longitudinally transected.Extremity a was bluntly cut while extremity b presented in a beveled fashion with monofilament blue suture in a continuous pattern along its edge, consistent with an anastomotic site.The ablumen was covered in thin layer of tan to yellow tissue and the blue alignment marks were faintly visible.An area of dark red/brown and yellow material was present near extremity b.The lumen at extremity a was devoid of tissue.Extremity b lumen was occluded by light tan tissue as confirmed by gore during on-site visit.Material disruptions (e.G., transections) were consistent with those caused by surgical instrumentation (e.G., scalpel, scissors) during a surgical procedure.The reported reason for removal was infection, source was not provided, and there was no accusation of infection being device related from the physician.Based on the explant scientist¿s review of the geprovas report and reason for removal, no additional analysis is requested.

• Brand Name: GORE-TEX® STRETCH VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14201693
• MDR Text Key: 290051475
• Report Number: 2017233-2022-02884
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132611317
• UDI-Public: 00733132611317
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K903931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/11/2022

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 Model Number: S0607
• Device Catalogue Number: S0607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/26/2022
• Supplement Dates Manufacturer Received: 06/14/2022
• Supplement Dates FDA Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2019
• 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 Sex: Male