BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II STENT GRAFT SYSTEM

    MDR report key: 2801953 · Received October 23, 2012

    Report

    Report Number
    2953200-2012-02026
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (VESSEL PERFORATION); CAUSED BY ANOTHER DRUG/DEVICE FAILURE (RELIANT BALLOON INFLATED PARTIALLY EXPOSED TO THE VESSEL WALL); INCORRECT TECHNIQUE/PROCEDURE (RELIANT BALLOON INFLATED PARTIALLY EXPOSED TO THE VESSEL WALL). EVALUATION, CONCLUSION: ANOTHER DEVICE CAUSED FAILURE (RELIANT BALLOON INFLATED PARTIALLY EXPOSED TO THE VESSEL WALL); OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (RELIANT BALLOON INFLATED PARTIALLY EXPOSED TO THE VESSEL WALL).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.2 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 25 MM IN LENGTH, 20, 20, 17 MM IN DIAMETER FROM PROXIMAL TO DISTAL WITH 45 DEGREE ANGULATION. THE ACCESS VESSELS WERE SMALL MEASURING 8 MM IN DIAMETER BILATERALLY AND THEY WERE SEVERELY CALCIFIED. THE AORTIC BIFURCATION WAS 18 MM IN DIAMETER. IT WAS REPORTED THAT THE PHYSICIAN HAD TO PUSH VERY HARD TO GET THE DELIVERY SYSTEM OF THE BIFURCATED STENT GRAFT INTO POSITION AND IN THE PROCESS TORE THE RIGHT FEMORAL ARTERY. THERE WAS NO REPORT OF DELIVERY SYSTEM KINK. THE FEMORAL ARTERY WAS SUCCESSFULLY SURGICALLY REPAIRED. THE CONTRALATERAL LIMB WAS IMPLANTED WITHOUT COMPLICATIONS. THEN AN IPSILATERAL LIMB WAS IMPLANTED ON THE RIGHT SIDE. A RELIANT BALLOON WAS USED TO POST-DILATE THE DISTAL END OF STENT AND PART OF NATIVE VESSEL WHICH WAS VERY SMALL AND DISEASED. THE BALLOON WAS PARTIALLY IN THE STENT GRAFT AND PARTIALLY EXPOSED TO THE VESSEL WHEN IT WAS INFLATED. THE RELIANT BALLOON PERFORATED THE RIGHT EXTERNAL ILIAC JUST BEYOND THE ILIAC BIFURCATION DURING POST INFLATIONS. THE PHYSICIAN HAD TO EXTEND ANOTHER DEVICE ON THE IPSILATERAL SIDE TO COVER PERFORATION. THERE WERE NO ENDOLEAKS AND THE PATIENT IS DOING FINE POST OPERATIVELY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT II STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01095180

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention