BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2102392 · Received May 20, 2011

    Report

    Report Number
    2953200-2011-01023
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ENDOLEAK; UNKNOWN CAUSE OF ENDOLEAK. CONCLUSIONS: UNKNOWN CAUSE OF ENDOLEAK.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE AORTIC NECK WAS CONICAL. THERE IS A REPORT OF A TYPE IV ENDOLEAK. APPROXIMATELY 2 CM DISTALLY, THE DEVICE NARROWS. THE PHYSICIAN RE-BALLOONED THAT AREA AFTER THE FIRST ANGIOGRAM, AND THEN BALLOONED WITH RELIANT. THE PATIENT WILL BE MONITORED IN 30 DAYS. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. FILM EVALUATION: REVIEW OF SEVERAL STILL IMAGES AT IMPLANT SHOW A POSSIBLE TYPE IV ENDOLEAK FROM THE LEFT SIDE OF THE STENT GRAFT; CANNOT CONFIRM THE EXACT LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00848114

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR