BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 6427070 · Received March 23, 2017

    Report

    Report Number
    2017233-2017-00142
    Event Type
    Death
    Date Received
    March 23, 2017
    Date of Event
    July 1, 2011
    Report Date
    April 4, 2017
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS THE LOT NUMBER REMAINS UNKNOWN. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO: VASCULAR TRAUMA (E.G., RUPTURE) AND DEATH.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS PRESENTED ON THE CONFERENCE ¿ ¿THE 47TH ANNUAL MEETING OF THE JAPANESE SOCIETY FOR CARDIOVASCULAR SURGERY¿ ON FEBRUARY 27, 2017. NOBUYA ZENPO ET AL, ¿REDUCTION IN ANEURYSM SIZE WITH DOUBLE CHIMNEY TEVAR USING UPSIDE DOWN EXCLUDER ILIAC EXTENDER¿ BETWEEN JULY 2010 AND AUGUST 2016, 36 PATIENTS UNDERWENT ENDOVASCULAR PROCEDURE USING CHIMNEY TECHNIQUE TO REPAIR ARCH ANEURYSM. A GORE® EXCLUDER® AAA ENDOPROSTHESIS ILIAC EXTENDER COMPONENT (ITEM NUMBER: PXL160407) WAS IMPLANTED IN THE BRACHIOCEPHALIC ARTERY AS CHIMNEY STENT-GRAFT FOR 12 PATIENTS. REGARDING THE 12 PATIENTS, THE ARTICLE STATES THAT ANEURYSM SHRINKAGE WAS CONFIRMED ONLY IN ONE PATIENT AND ONE PATIENT EXPIRED DUE TO RUPTURE OF THE TREATMENT AREA APPROXIMATELY ONE YEAR AFTER THE PROCEDURE. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211136 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Death