BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 4111771 · Received September 23, 2014

    Report

    Report Number
    2953200-2014-01906
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS REPORTED AS THERE WAS SEVERE CIRCUMFERENTIAL CALCIFICATION IN THE DISTAL AORTA AND THE AORTIC BIFURCATION WAS NARROW, MEASURING 8 X 11MM. THE PHYSICIAN MODELLED THE STENT GRAFT WITH A BALLOON AND IT ALL LOOKED FINE. THE PHYSICIAN DID NOT PERFORM A KISSING BALLOON TECHNIQUE. THE FOLLOWING DAY THE PATIENT CAME BACK WITH RIGHT LIMB OCCLUSION. THE PHYSICIAN CLEANED OUT LIMB AND PLACED 10X40 SELF -EXPANDING BARE STENT ACROSS THE RIGHT HYPOGASTRIC ARTERY PREVENTING THE A CLOT ADVANCING INTO THE HYPOGASTRIC ARTERY. THEN PLACED BI-LATERAL 10X29 BALLOON EXP. STENTS AT THE AORTIC BIFURCATION IN NARROW/TIGHT AREA. THEN PLACED 14 X 6 SELF-EXPANDING STENT IN RIGHT ILIAC TO PIN THE CLOT AGAINST THE WALL. THE FINAL ANGIOGRAM REVEALED THAT BOTH ILIAC LIMBS HAD RESTORED BLOOD FLOW AND WIDELY PATENT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591462 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04205444

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention