BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

    MDR report key: 22642419 · Received July 29, 2025

    Report

    Report Number
    3007284313-2025-04152
    Event Type
    Death
    Date Received
    July 29, 2025
    Date of Event
    July 2, 2025
    Report Date
    September 12, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132634644
    PMA / PMN Number
    P200030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE FOR AN EMERGENT RUPTURED PARARENAL ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX). REPORTEDLY, PHYSICIAN DECIDED TO TREAT WITH AN ARTIVION DEVICE AND USE VBX FOR THE BRANCHES AND AN EXCLUDER CONFORMABLE FOR THE ABDOMINAL BRIDGING STENTS. PHYSICIAN COULD NOT ACCESS THE RENAL ARTERIES DUE TO PATIENT'S ANATOMICAL CHALLENGES AS BOTH RENALS WERE SMALL AND HAD POOR PATENCY, THUS, DECIDED TO PUT THE EXCLUDER CONFORMABLE GRAFT OVER THE RENAL BRANCHES. PHYSICIAN WAS AWARE THAT THEY WOULD NEED TO COVER AT LEAST ONE RENAL (RIGHT) DUE TO THE ANATOMY BUT TRIED TO PRESERVE THE LEFT WITH THE BAIL OUT TO COVER AS DONE DURING THE PROCEDURE. THE ANGIO APPEARED TO SHOW THAT THEY HAVE SEALED THE AAA. THEY THEN HAD TO EVACUATE/SUCTION THE PATIENT'S ABDOMEN DUE TO BLOOD LOSS FILLING DURING THE PROCEDURE BUT WHEN THEY OPENED THE PATIENT'S ABDOMEN, THEY DISCOVERED THE AAA WAS NOT FULLY SEALED AND IT WAS STILL LEAKING BUT UNSURE OF THE ORIGIN. PHYSICIAN WAS UNABLE TO SEAL SURGICALLY AS THERE WAS TOO MUCH BLOOD LOSS AND THE PATIENT EXPIRED DURING PROCEDURE WITH PHYSICIAN STATING CAUSE OF DEATH BEING DUE TO THE UNSEALED RUPTURED AAA AND IS UNRELATED TO GORE GRAFTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061352 GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 29654913 00733132634644

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Other| R| D