BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BGORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3082950 · Received April 23, 2013

    Report

    Report Number
    3007284313-2013-00030
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    W.L. GORE & ASSOCAITES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 PT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES FOR THE TREATMENT OF A 4.9 CM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED A QXMEDICAL Q50-65P STENT GRAFT BALLOON CATHETER WAS PLACED WITHIN THE CONTRALATERAL LEG COMPONENT AND INFLATED TO 18 MM USING 30 CC OF SALINE SOLUTION. THE COMMON ILIAC ARTERY (MEASURING 13 MM) RUPTURED DURING THE BALLOONING OF THE GRAFT. THE RUPTURE WAS REPAIRED WITH ANOTHER CONTRALATERAL LEG COMPONENT AND THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174371 BGORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCAITES 11119667

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R NITROGLYCERIN| ASPIRIN| INSULIN| CITALOPRAM| BENAZEPRIL