BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2221251 · Received August 17, 2011

    Report

    Report Number
    2017233-2011-00425
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 27, 2011
    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), 2011, THE PT UNDERWENT REPAIR OF AN ABDOMINAL AORTIC ANEURYSM. THE PT HAD A HEAVILY CALCIFIED COMMON ILIAC ARTERY CAUSING TIGHT ACCESS. THE SHEATH MET RESISTANCE AND WAS FORCIBLY ADVANCED. THE DEVICE WAS ADVANCED OUTSIDE OF THE SHEATH. THE DEPLOYMENT LINE WAS PULLED; HOWEVER, THE DEVICE DID NOT DEPLOY. THE DEVICE WAS REMOVED. ANOTHER TRUNK-IPSILATERAL LEG COMPONENT WAS IMPLANTED. LATER THAT DAY, A HEMATOMA WAS NOTED AT THE ACCESS SITE. THERE WAS A TEAR AT THE ACCESS SITE WHICH WAS STITCHED UP. THE PT TOLERATED THE PROCEDURE. THE DEVICE HAS BEEN RETURNED TO GORE AND IS UNDER EVAL.

    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 8309958

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R METANX| METFORMIN| ZOCOR| NORVASC| LOPID| ASPIRIN| ZESTRIL