BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2984053 · Received February 28, 2013

    Report

    Report Number
    2953200-2013-00361
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (SURGICAL CONVERSION); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (SMALL DISEASED DISTAL AORTA AND SEVERELY CALCIFIED VESSELS); INCORRECT TECHNIQUE/PROCEDURE (STENT GRAFT WAS USED FOR TREATMENT OF A PATIENT WITH A <(><<)> 19 MM DIAMETER AORTIC NECK); CAUSED BY ANOTHER DRUG/DEVICE (OTHER MANUFACTURER'S WIRE LIKELY CAUSED STROKE). CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (SMALL DISEASED DISTAL AORTA AND SEVERELY CALCIFIED VESSELS); USER ERROR CONTRIBUTED TO EVENT (STENT GRAFT WAS USED FOR TREATMENT OF A PATIENT WITH A <(><<)> 19 MM DIAMETER AORTIC NECK); ANOTHER DEVICE CAUSED FAILURE (OTHER MANUFACTURER'S WIRE LIKELY CAUSED STROKE).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 43 MM DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. THE AORTIC NECK WAS 17-18 MM IN DIAMETER. THE NECK WAS MODERATELY ANGULATED WITH MILD THROMBUS AND MODERATE CALCIFICATION. THE TERMINAL AORTA WAS SMALL AND DISEASED, AND THE ILIAC ARTERIES WERE SEVERELY CALCIFIED. IT WAS REPORTED THAT AFTER DEPLOYMENT OF THE BIFURCATED STENT GRAFT FROM THE RIGHT SIDE THE PHYSICIAN WAS UNABLE TO WIRE THE GATE FROM BELOW THROUGH THE LEFT SIDE. GOING UP AND OVER FROM THE RIGHT SIDE WAS ALSO UNSUCCESSFUL. THE PHYSICIAN THEN ATTEMPTED TO BRING A WIRE AND CATHETER DOWN THE DESCENDING AORTA FROM THE LEFT BRACHIAL APPROACH. THIS WAS ALSO UNSUCCESSFUL DUE TO AN ANOMALOUS ARCH. THE PHYSICIAN FINALLY DECIDED TO CONVERT TO THE STENT GRAFT TO AN AORTO-UNI-ILIAC. AN ENDURANT CUFF WAS PLACED IN THE FLOW DIVIDER OF THE BIFURCATED STENT GRAFT AND EXTENDED 2 CM INTO THE RIGHT ILIAC. A 10X4 ASSURANT STENT WAS THEN USED TO IRON OUT THE OVERSIZED CUFF. A VASCULAR PLUG WAS THEN PLACED IN THE LEFT COMMON ILIAC ARTERY. THE WIRE FROM ANOTHER MANUFACTURER, WOULD NOT DETACH FROM THE PLUG, BUT SINCE A FEM-FEM BYPASS WAS ALSO BEING PERFORMED, THE PHYSICIAN CUT THE WIRE PROXIMAL TO WHERE THE EXTERNAL ILIAC WAS LIGATED. THREE DAYS POST IMPLANT THE PATIENT SUFFERED A STROKE. THE PHYSICIAN BELIEVES THE ATTEMPT TO GET A WIRE DOWN THE DESCENDING THORACIC AORTA MAY HAVE CAUSE A PLAQUE TO BECOME DISLODGED RESULTING IN THE STROKE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86384 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03022844

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR