BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 2153234 · Received June 23, 2011

    Report

    Report Number
    2953200-2011-01184
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 25, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (ARTERIAL/VESSEL OCCLUSION), (BARE METAL STENT FROM ANOTHER MFR). CONCLUSION: (BARE METAL STENT FROM ANOTHER MFR).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 2 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. THE ENDURANT BIFURCATED STENT GRAFT WAS IMPLANTED W/O ISSUES, AND A BARE METAL STENT FROM ANOTHER MFR HAD BEEN PLACED IN THE RENAL ARTERY. IT WAS REPORTED THAT THE 30 DAY CT SCAN REVEALED THAT THERE WAS AN EXTRUDED SOFT PLAQUE FROM THE BARE METAL STENT. THROMBUS, WHICH COVERED APPROX 100 DEGREES OF THE POSTERIOR AORTA AT THE LEVEL OF THE RENAL ARTERIES, HAD MOVED INTO THE LUMEN OF THE AORTA. THE PHYSICIAN HAS PLANNED TO INTERVENE AT A LATER DATE. 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 STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00831454

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention