BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II

    MDR report key: 3092221 · Received May 3, 2013

    Report

    Report Number
    2953200-2013-00823
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: KINK. ANATOMY RELATED; SEVERE VESSEL TORTUOSITY. CONCLUSION: ANATOMY RELATED; SEVERE VESSEL TORTUOSITY.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS SELECTED (BUT, NOT IMPLANTED IN THE PATIENT) FOR THE ENDOVASCULAR TREATMENT OF A 5.5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE VESSEL MORPHOLOGY WAS REPORTED AS THERE WAS SEVERE TORTUOSITY THROUGHOUT THE VESSELS. IT WAS REPORTED THAT THE PHYSICIAN IMPLANTED THE BIFURCATED STENT GRAFT AND IPSILATERAL EXTENSION WITHOUT ISSUE. THE PHYSICIAN HAD DIFFICULTIES BUT WAS ABLE TO ADVANCE THE LUNDERQUIST WIRE THROUGH THE CONTRALATERAL GATE DUE TO THE PATIENT ANATOMY. THE PHYSICIAN INSERTED THE ENDURANT CONTRALATERAL LIMB HOWEVER THE STENT GRAFT DELIVERY SYSTEM WAS UNABLE TO BE ADVANCED TO THE INTENDED LESION SITE DUE TO THE PATIENT'S ANATOMY. THE STENT GRAFT DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AND THERE WERE SEVERAL KINKS IN THE DELIVERY SYSTEM. THE STENT GRAFT WAS NOT IMPLANTED IN THE PATIENT. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER MANUFACTURER'S CONTRALATERAL ILIAC LIMB. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193915 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03993073

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR