BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2241057 · Received August 17, 2011

    Report

    Report Number
    2953200-2011-01453
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 19, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: DEPLOYMENT FAILURE. VESSEL TORTUOSITY. EVAL, CONCLUSION: VESSEL TORTUOSITY.

    Description of Event or Problem · 1

    AN ENDURANT BIFURCATED STENT GRAFT SYSTEM WAS INSERTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF AN UNK SIZE. VESSELS WERE MODERATELY TORTUOUS AND MILDLY CALCIFIED. IT WAS REPORTED THAT THE STENT GRAFT DELIVERY SYSTEM WAS ADVANCED WITHOUT ISSUES IN THE ABDOMINAL AORTA; HOWEVER, DURING DEPLOYMENT, THE PHYSICIAN FELT HEAVY RESISTANCE WHILE ROTATING THE HANDLE. AS THE RESISTANCE WAS CONSIDERED UNUSUAL, THE PHYSICIAN ELECTED TO ABORT THE PROCEDURE. THE FEMORAL ACCESS WAS CLOSED, BUT THE INTERVENTION WAS POSTPONED. THE PHYSICIAN THEN TRIED TO DEPLOY THE STENT GRAFT ON THE STERILE TABLE, WHICH WAS COMPLETED WITH GREAT DIFFICULTY. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE. THE DELIVERY SYSTEM HAS BEEN RECEIVED BY MEDTRONIC, AND ITS EVAL IS PENDING. AN INTERNAL REVIEW OF THE ANGIOGRAM OF THE ATTEMPTED IMPLANTATION WERE INCONCLUSIVE AS TO THE POSSIBLE CAUSE OF THE DEPLOYMENT DIFFICULTIES. THE BIFURCATED STENT GRAFT DELIVERY SYSTEM WAS BROUGHT UP TO POSITION AT THE RENAL ARTERIES VIA THE RIGHT SIDE; THE ILIAC ARTERIES DID NOT APPEAR VERY TORTUOUS. DEPLOYMENT WAS NOT SEEN ON THE ANGIOGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00882753

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK