BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2191207 · Received July 29, 2011

    Report

    Report Number
    2953200-2011-01354
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS AND CONCLUSIONS: (NARROW DISTAL AORTA WITH CALCIUM), (OTHER MFR'S DEVICE).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 7.5 CM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS A NARROW AORTIC BIFURCATION. IT WAS REPORTED THAT THE IMPLANT OF THE BIFURCATED STENT GRAFT WENT WELL. THE PHYSICIAN PLACED ANOTHER MFR'S STENT IN THE RIGHT ILIAC LIMB, DUE TO THE NARROW BIFURCATION. AFTER THE STENT WAS DEPLOYED, THE PHYSICIAN DEFLATED THE BALLOON AND UPON RETRIEVING THE BALLOON BACK INTO THE CATHETER, THE STENT PULLED BACK WITH THE BALLOON INTO THE COMMON ILIAC ARTERY RESULTING IN A PARTIAL OCCLUSION. THE STENT WAS THEN PULLED BACK TO THE BIFURCATION OF THE HYPOGASTRIC ARTERY, WHERE THE PHYSICIAN DECIDED TO LEAVE IT. AN INTERNAL REVIEW OF FILMS CONFIRMED A NARROW DISTAL AORTA WHICH WAS 16-18 MM DIAMETER WITH CALCIUM. NO 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 SYSTEM MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00886198

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR