BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3143111 · Received May 29, 2013

    Report

    Report Number
    2017233-2013-00345
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 3, 2012
    Report Date
    May 3, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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) 2013, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH A GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 DELIVERY SYSTEM. AFTER DEPLOYMENT OF THE TRUNK, THERE WAS DIFFICULTY CANNULATING THE CONTRALATERAL GATE. IT WAS REPORTED THE DEVICE WAS RECONSTRAINED AND TWISTED IN ORDER TO GET A BETTER ANGLE FOR CANNULATION. THE GATE WAS SUCCESSFULLY CANNULATED, AND THE DEVICE WAS REPORTEDLY DEPLOYED WITHOUT UNTWISTING THE DEVICE AND RETURNING IT TO IT'S INTENDED DEPLOYMENT POSITION. FINAL ANGIOGRAPHY SHOWED THE IPSILATERAL LIMB APPEARED KINKED APPROXIMATELY 6 CM FROM THE DISTAL WAIST. ADDITIONAL ANGIOPLASTY WAS PERFORMED, BUT THE KINKING DID NOT RESOLVE. AN ADDITIONAL STENT WAS IMPLANTED INTO THE IPSILATERAL LIMB. IT WAS REPORTED IMAGING SHOWED THE IPSILATERAL LIMB STILL APPEARED SLIGHTLY NARROWED AND THE DEVICE APPEARED TO BE OPEN ONLY 11-12 MM. THE PHYSICIAN ELECTED TO CONCLUDE THE PROCEDURE. FINAL IMAGING SHOWED EXCLUSION OF THE ANEURYSM, AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235401 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 9869275

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R PRILOSEC| SYNTHROID| LIPITOR| RANEXA| NORVASC| NITRO-STAT| IMDUR| TOPROLOL| ASPIRIN