BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER BIFURCATED ENDOPROSTHESIS

    MDR report key: 2221252 · Received August 17, 2011

    Report

    Report Number
    2953161-2011-00179
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 10, 2003
    Report Date
    August 16, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6), 2003, THIS PT UNDERWENT TREATMENT OF AN INFRARENAL ABDOMINAL AORTIC ANEURYSM WITH TWO GORE EXCLUDER BIFURCATED ENDOPROSTHESES. A COMPLETION ARTERIOGRAM REPORTEDLY SHOWED NO EVIDENCE OF ENDOLEAK; HOWEVER, IT WAS REPORTED THAT THERE APPEARED TO BE SOME CONSTRICTION OF THE RIGHT GRAFT LIMB AT THE ORIGIN OF THE RIGHT COMMON ILIAC ARTERY. ADDITIONAL ANGIOPLASTY WAS PERFORMED, AND AN ARTERIOGRAM SHOWED NO RESIDUAL STENOSIS, PATENCY OF BOTH GRAFT LIMBS, AND GOOD FLOW TO THE HYPOGASTRIC ARTERIES. THE PT HAD PALPABLE POSTERIOR TIBIAL PULSES BILATERALLY AND WAS SENT TO RECOVERY IN STABLE CONDITION. ON (B)(6), 2011, AN ADDITIONAL PROCEDURE WAS PERFORMED WHEREBY TWO CONTRALATERAL LEG COMPONENTS. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER BIFURCATED ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES WLG325 022811805

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R (B)(4)