BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 4618407 · Received March 19, 2015

    Report

    Report Number
    2017233-2015-00163
    Event Type
    Injury
    Date Received
    March 19, 2015
    Date of Event
    February 5, 2015
    Report Date
    May 4, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).PATIENT¿S MEDICATIONS INCLUDE: ZOLPIDERM, SPIRONOLACTONE, ATORVASTATIN, AMLODIPINE BESYLATE, SYNTHROID, XARELTO, CALCITRIOL, ALLOPURINOL, SOTALOL, AND TAMSULOSIN.

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICES IMPLANTED AND INVOLVED: PXC201400/8270013, AND PXL161407/7862340.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH THREE GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2015, A SUSPECTED ENDOLEAK (TYPE UNKNOWN) WAS IDENTIFIED ON THE TRUNK-IPSILATERAL LEG COMPONENT. IT WAS REPORTED THE CAUSE OF THE ENDOLEAK IS UNKNOWN. IT WAS REPORTED ANEURYSM ENLARGEMENT OF 6MM WAS IDENTIFIED (4.6-5.2CM). ON (B)(6) 2015, COIL EMBOLIZATION OF THE ANEURYSM SAC WAS PERFORMED TO ADDRESS THE TYPE II ENDOLEAK. IT WAS REPORTED THE ENDOLEAK WAS EXCLUDED AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187268 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8352029

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R