BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2936251 · Received January 30, 2013

    Report

    Report Number
    2953200-2013-00171
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INCORRECT TECHNIQUE/PROCEDURE (INACCURATE POSITIONING OF THE CONTRALATERAL LIMB). CONCLUSION: OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (INACCURATE POSITIONING OF THE CONTRALATERAL LIMB).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY THREE WEEKS AGO. THE AORTIC NECK WAS 28 MM IN DIAMETER AND 10 MM IN LENGTH. AN ENDURANT BIFURCATED STENT GRAFT 3216145 A 1613156 CONTRALATERAL LIMB AND A 161682, IPSILATERAL EXTENSION WERE IMPLANTED. IT WAS REPORTED THAT AFTER THE BIFURCATED STENT GRAFT WAS DEPLOYED A WIRE WAS PLACED INTO THE CONTRALATERAL GATE. THE CONTRALATERAL LIMB WAS INSERTED AND PLACED ACCURATELY; HOWEVER, DUE TO POOR IMAGING AND PHYSICIAN ERROR THE STENT GRAFT MOVED UP AND WAS DEPLOYED 3 CM FARTHER THAN INTENDED. NO INTERVENTION WAS REQUIRED TO BE DONE. THERE WAS A SLIGHT PROXIMAL TYPE I ENDOLEAK THAT WAS LEFT UNTREATED BECAUSE THERE WAS NO ROOM TO PLACE AN AORTIC CUFF. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41689 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01085550

    Patients

    Seq Age Sex Outcome Treatment
    1