BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 6149766 · Received December 6, 2016

    Report

    Report Number
    2017233-2016-00909
    Event Type
    Death
    Date Received
    December 6, 2016
    Date of Event
    August 29, 2016
    Report Date
    December 9, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), THE SAFETY AND EFFECTIVENESS OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS HAS NOT BEEN EVALUATED IN THE FOLLOWING PATIENT POPULATIONS: LEAKING: PENDING RUPTURE OR RUPTURED ANEURYSMS

    Additional Manufacturer Narrative · 1

    (B)(4). AS GORE WAS UNABLE TO DETERMINE WHICH DEVICE WAS INVOLVED IN THE EVENT IF ANY; CONCOMITANT MEDICAL PRODUCTS: PLC181200/13495094,PLC181000/13675373, PXC121400/14592021, PXC121200/13608456.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH FIVE GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT WAS REPORTED TO HAVE EXPIRED THIS SAME DAY. THE CAUSE OF DEATH WAS NOT PROVIDED, BUT IT WAS REPORTED THAT THERE WERE NO DEVICE RELATED DEFICIENCIES DURING THE PROCEDURE.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT AND WAS IMPLANTED WITH FIVE GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT WAS REPORTED TO HAVE EXPIRED THIS SAME DAY. THE CAUSE OF DEATH WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798796 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 11815166

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death