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

Model Number ST0807

Device Problem Contamination (1120)

Patient Problem Post Operative Wound Infection (2446)

Event Date 10/28/2021

Event Type  Injury  

Event Description

It was reported to gore that the patient presented on (b)(6) 2021 with massive bleeding due to arterial perforation with a large sheath during endovascular treatment for a transcatheter aortic valve implantation (tavi).In an emergency surgical treatment an ilio-femoral bypass was performed with a gore-tex® stretch vascular graft thin-walled.Reportedly, on (b)(6) 2021, after about one month, the prosthesis was explanted due to an bacterial wound infection with proteus mirabilis, morganella morganiiet and enterococcus faecalis bacteries.It was stated that the explanted device was replaced with an allograft.

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.

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 53 mm in length with both ends transected.The ablumen was covered in thin light tan tissue and the blue alignment marks were clearly visible.Both ends of the graft had regions of blue monofilament suture in a continuous running pattern which appear to be anastomosed to native light tan to dark brown tissue.The lumen at extremity a is completely covered by tissue rendering the graft non-visible, extremity b is partially covered by tissue, the portion of lumen visible was generally devoid of tissue.The patency of the graft fragment could not be clearly determined based on the analysis or images provided.Material disruptions (e.G., transections and sutures) were consistent with those caused by surgical instrumentation (e.G., scalpel, scissors, suture) used during a surgical procedure.Based on the explant scientist¿s review of the geprovas report, no additional analysis is requested.The reported reason for removal was infection, type and source were not provided, and there was no accusation of infection being device related from the physician.

Manufacturer Narrative

Product history review: all of the sterilization documents were reviewed.The sterilization batch was processed in accordance with standard operating procedures and met all processing requirements.

• 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
• 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: 13533962
• MDR Text Key: 286961073
• Report Number: 2017233-2022-02745
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132612758
• UDI-Public: 00733132612758
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2022

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: ST0807
• Device Catalogue Number: ST0807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 02/15/2022
• Supplement Dates Manufacturer Received: 06/14/2022; 07/20/2022
• Supplement Dates FDA Received: 07/11/2022; 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2019
• 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: 77 YR
• Patient Sex: Female