BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT

    MDR report key: 2201141 · Received July 29, 2011

    Report

    Report Number
    2953200-2011-01359
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ENDOLEAK. CONCLUSION: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    AN ENDURANT BIFURCATED STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE UNREMARKABLE. IT WAS REPORTED THAT THERE WAS A SUBTLE TYPE IV ENDOLEAK POST IMPLANT. THE ENDOLEAK WAS LOCATED ABOVE THE FLOW DIVIDER. FIXED IMAGING WAS USED. NO INTERVENTION WAS PERFORMED. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00888239

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR