BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2230416 · Received August 15, 2011

    Report

    Report Number
    2953200-2011-01440
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF EVALUATION: OCCLUSION, RUPTURE/PERFORATION. CALCIFIED VESSELS. CLOSURE DEVICE. CONCLUSION: CALCIFIED VESSELS. USE OF A CLOSURE DEVICE.

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 1.5 MONTHS AGO VIA PERCUTANEOUS ACCESS. IT WAS REPORTED THAT THE PATIENT RETURNED WITH AN OCCLUSION OF THE FEMORAL ARTERY, WHERE THE VESSEL HAD BEEN CLOSED, AND THERE WAS NO BLOOD FLOW DOWN TO THE LEG. THE OCCLUSION MAY HAVE BEEN DUE TO THE CLOSURE DEVICE FROM ANOTHER MANUFACTURER, AS THE VESSEL MIGHT HAVE BEEN CLOSED TOO TIGHTLY. THE PHYSICIAN ELECTED TO INTERVENE BY USING A BALLOON FROM ANOTHER MANUFACTURER TO BALLOON THE FEMORAL ARTERY, DURING THE BALLOONING, THE FEMORAL ARTERY RUPTURED, WHICH THE PHYSICIAN ELECTED TO REPAIR WITH A STENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE. AN INTERNAL REVIEW OF RETURNED PRE-IMPLANT FILMS SHOWED CALCIFIED VESSELS. THE VESSEL RUPTURE AND OCCLUSION EVENTS COULD NOT BE EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00889249

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention