BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2233945 · Received August 30, 2011

    Report

    Report Number
    2953161-2011-00184
    Event Type
    Injury
    Date Received
    August 30, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 29, 2011
    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

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PT WAS IMPLANTED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT A 7CM ABDOMINAL AORTIC ANEURYSM. IN (B)(6) 2010 (EXACT DATE UNK), A ROUTINE COMPUTED TOMOGRAPHY REVEALED SLIGHT ANEURYSM GROWTH. THE ANEURYSM MEASURED 7.3CM. ON (B)(6) 2011, A COMPUTED TOMOGRAPHY REVEALED A POSSIBLE TYPE II ENDOLEAK ORIGINATING FROM A COLLATERAL VESSEL WITHIN THE ILIAC ARTERY AND ANEURYSM GROWTH OF APPROX 3CM. THE ANEURYSM NOW MEASURES 10.22. ON (B)(6) 2011, AN ANGIOGRAM CONFIRMED THE ANEURYSM GROWTH AND THE POSSIBLE TYPE II ENDOLEAK. THE PT WAS ADMITTED INTO THE HOSPITAL DUE TO THE ANEURYSM GROWTH. ON (B)(6) 2011, THE PT'S HAD TWO TORNADO COILS IMPLANTED BILATERALLY IN THE INTERNAL ILIAC ARTERIES TO TREAT THE ENDOLEAK AND ANEURYSM GROWTH. THE PT TOLERATED THE PROCEDURE AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES WLG425 06679199

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R THE PT'S MEDICATIONS INCLUDE LOPRESSOR| PROSCAR.| ZOCAR| ASAPRIN| PRILOSEC AND