BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 7164354 · Received January 4, 2018

    Report

    Report Number
    3007284313-2018-00003
    Event Type
    Death
    Date Received
    January 4, 2018
    Date of Event
    November 2, 2017
    Report Date
    January 15, 2018
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES IMPLANTED AND INVOLVED IN THIS EVENT: PXL161207/15378586 AND PLC231400/16579736. UDI NUMBERS FOR THE LOTS ARE AS FOLLOWS: LOT 15170882: UDI (B)(4). LOT 15378586: UDI (B)(4). LOT 16579736: UDI (B)(4). CONCOMITANT PRODUCT(S): THE PATIENT¿S MEDICATIONS INCLUDE; ALBUTEROL, LIPITOR, ATIVAN, CROTAX, SPIRIVA, ELIQUIS, COLACE, MAGNESIUM OXIDE, MIRALAX, ULTRAM, ASPIRIN, PERCOCET, AND RANEXA.

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO EMBOLIZATION (MICRO AND MACRO) WITH TRANSIENT OR PERMANENT ISCHEMIA , NEUROLOGIC DAMAGE, LOCAL OR SYSTEMIC (E.G., STROKE, PARAPLEGIA, PARAPARESIS) AND DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH THREE GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED, AN ADDITIONAL PROCEDURE (UNKNOWN) WAS PERFORMED FOR TREATMENT OF THE PATIENT¿S CRITICAL LOWER LIMB ISCHEMIA DUE TO CHRONIC PERIPHERAL ARTERY DISEASE. ACCORDING TO THE REPORT, THERE WERE NO COMPLICATIONS DURING THE IMPLANTATION PROCEDURE, HOWEVER THE PATIENT SUFFERED SPINAL CORD INFARCTION (ISCHEMIC STROKE) WITH ACUTE PARAPLEGIA WHILE IN RECOVERY. THE PHYSICIAN STATED THE EXACT CAUSE OF STROKE IS REPORTEDLY UNKNOWN. ON (B)(6) 2017, THE PATIENT WAS REPORTED TO HAVE EXPIRED. THE PHYSICIAN ATTRIBUTES THE PATIENT¿S DEATH TO THE SPINAL CORD INFARCTION. THE PHYSICIAN STATED THE ENDOVASCULAR PROCEDURE AND NOT THE GORE DEVICES CAUSED THE SPINAL CORD ISCHEMIA. AN AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7883 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 15170882

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death