BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

    MDR report key: 17317866 · Received July 13, 2023

    Report

    Report Number
    3007284313-2023-02628
    Event Type
    Malfunction
    Date Received
    July 13, 2023
    Date of Event
    June 28, 2023
    Report Date
    July 13, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132651016
    PMA / PMN Number
    P200030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CODE C19: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. CODE B20: THE DEVICE REMAINS IMPLANTED AND WAS THEREFORE NOT AVAILABLE FOR ENGINEERING EVALUATION BY GORE. 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. 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) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR ZONE 9 INFRARENAL AORTO ILIAC UNILATERAL IBE PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. REPORTEDLY, THE DEVICE WAS PLACED IN A VERY TORTUOUS PROXIMAL NECK. THE DEVICE WAS DEPLOYED APPROPRIATELY AND UPON REMOVAL, THE OLIVE TIP BROKE OFF (SHEARED) INSIDE OF THE PATIENT POST DEPLOYMENT. AS THE DELIVERY SYSTEM WAS TAKEN OUT OVER THE WIRE, IT WAS NOTICED THE OLIVE TIP STAYED ON THE WIRE AS DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT ENDOVASCULARLY WITH AN ENSNARE DEVICE WITHOUT ISSUE. THERE WAS NO ABILITY TO OBTAIN THE BROKEN TIP ON THE TRUNK AS BOTH THE OLIVE TIP AND DELIVERY SYSTEM WERE DISCARDED BEFORE RETRIEVING. PATIENT TOLERATED THE PROCEDURE WELL WITH NO EXTRANEOUS EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312163 GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. CXT231412 00733132651016

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization| R