BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 5114622 · Received September 30, 2015

    Report

    Report Number
    2017233-2015-00662
    Event Type
    Injury
    Date Received
    September 30, 2015
    Date of Event
    September 10, 2015
    Report Date
    September 10, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL EXCLUDER® DEVICE INCLUDED IN THIS REPORT: PXC201400/7081416. DEVICE UDI'S PXC201200/7061675: (B)(4) PXC201400/7081416: (B)(4). CONCOMITANT MEDICAL PRODUCTS: PATIENT MEDICATIONS INCLUDE PRILOSEC, DITROPAN, METHOTREXATE, FLOMAX, LIPITOR, COUMADIN, METOPROLOL, PROSCAR, REMICADE, ASPIRIN, AND A MULTIVITAMIN. IMAGING EVALUATION FINDINGS: POST-IMPLANT CT IMAGES DATED (B)(6) 2015 WERE RECEIVED BY GORE FROM THE FACILITY, AND AN IMAGING EVALUATION WAS PERFORMED. THE DISTAL END OF THE CONTRA-LATERAL LIMB DID NOT APPEAR TO BE CIRCUMFERENTIALLY TOUCHING THE WALL OF THE LEFT COMMON ILIAC ARTERY. THERE DID NOT APPEAR TO BE CONTRAST VISIBLE OUTSIDE IMPLANTED DEVICES WITHIN THE ABDOMINAL AORTA. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICES VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS. PER THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ANEURYSM ENLARGEMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON AN UNKNOWN DATE IN (B)(6) 2015, COMPUTED TOMOGRAPHY (CT) SCAN REPORTEDLY IDENTIFIED LEFT COMMON ILIAC ARTERY DILATATION, CAUSING A 20MM BELL-BOTTOM LIMB TO LOSE APPOSITION TO THE VESSEL WALL. ACCORDING TO THE REPORT, THE DILATED ILIAC ARTERY WAS A RESULT OF ANEURYSMAL DISEASE PROGRESSION OVER TIME. ON (B)(6) 2015, THE PHYSICIAN EMBOLIZED THE LEFT INTERNAL ILIAC ARTERY, AND THEN EXTENDED THE EXISTING ENDOGRAFT SYSTEM ON THE LEFT SIDE WITH AN ADDITIONAL GORE EXCLUDER CONTRALATERAL LEG COMPONENT. CIRCUMFERENTIAL DEVICE APPOSITION WAS RESTORED, AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645019 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7061675

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R