BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3122504 · Received May 15, 2013

    Report

    Report Number
    2017233-2013-00308
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    January 9, 2013
    Report Date
    April 25, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2013, FOLLOW UP CT IMAGES SHOWED ANEURYSM GROWTH FROM 5 CM TO 5.5. CM AND PROXIMAL MIGRATION OF THE CONTRALATERAL LEG COMPONENT. IT WAS REPORTED THE LEFT COMMON ILIAC ARTERY WAS REPORTEDLY SHORT, AND THERE WAS AN EXCESSIVE AMOUNT OF THROMBUS IN THE ILIAC ARTERIES. THE INADEQUATE SEAL ZONE, IN ADDITION TO THE EXCESSIVE THROMBUS, REPORTEDLY LED TO THE CONTRALATERAL LEG COMPONENT PULLING UPWARDS 3 CM INTO THE ANEURYSM SAC. ON (B)(6) 2013, A REINTERVENTION WAS PERFORMED WHEREBY AN ADDITIONAL CONTRALATERAL LEG COMPONENT AND AN ILIAC EXTENDER COMPONENT WERE IMPLANTED FOR DISTAL EXTENSION INTO THE PATIENT'S LEFT COMMON AND EXTERNAL ILIAC ARTERIES. FINAL IMAGING SHOWED EXCLUSION OF THE ANEURYSM, AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215159 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7631351

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R PLAVIX| ATENOLOL| ALBUTEROL| IPRATROPIUM