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
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	10/28/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 2017233-2022-02745
• Device Sequence Number: 14783519
• Product Code: DSY
• UDI-Device Identifier: 00733132612758
• UDI-Public: 00733132612758
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K903931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 09/15/2024
• Device Model Number: ST0807
• Device Catalogue Number: ST0807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 06/14/2022; 07/20/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 07/11/2022; 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female