BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3071498 · Received April 22, 2013

    Report

    Report Number
    2953200-2013-00748
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 24, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; VESSELS TORTUOSITY). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; VESSELS TORTUOSITY).

    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, COMMON ILIAC ARTERY ANEURYSM, RIGHT EXTERNAL ILIAC ARTERY ANEURYSM, WITH THE 20 DEGREE AORTIC NECK ANGULATION. THE VESSEL MORPHOLOGY WAS REPORTED AS THE PROXIMAL NECK WAS 22MM IN DIAMETER AND 21MM AT THE ANEURYSM ENTRANCE. THE PROXIMAL NECK LENGTH WAS 20MM IN DIAMETER AND THE DIAMETER OF THE ANEURYSM WAS 45MM. THE VESSEL DIAMETER OF RIGHT COMMON ILIAC ARTERY WAS 65MM. THE RIGHT COMMON ILIAC LENGTH WAS 85MM IN DIAMETER AND THE LEFT COMMON ILIAC ARTERY LENGTH WAS 67MM. THE ANEURYSM LENGTH WAS 120MM IN DIAMETER. DURING A ROUTINE FOLLOW UP, IT WAS DISCOVERED THAT THERE WAS NO PULSE IN THE PATIENT'S RIGHT DISTAL LIMB. IT WAS REPORTED THAT THERE WAS STENT GRAFT KINKING DUE TO THE VESSEL TORTUOSITY, AS THERE WAS ANGULATION IN THE RIGHT ILIAC ARTERY. THE PHYSICIAN ELECTED TO REMOVE THE THROMBOSIS AND IMPLANTED A STENT (BARE METAL STENT).HOWEVER; THE PATIENT STILL HAD POOR BLOOD FLOW AND WEAK/FEEBLE PULSE. THE PHYSICIAN ELECTED TO PERFORM A FEMORAL TO FEMORAL BYPASS. THE PHYSICIAN WILL MONITOR THE PATIENT. THE PATIENT IS FINE. NO ADDITIONAL CLINICAL SEQUEL AE WERE REPORTED. PHYSICIAN'S COMMENTS: IT IS POSSIBLE THAT THE BLOOD FORM HAS CHANGED DAY BY DAY AFTER EVAR, WHICH WOULD LEAD TO OCCLUSION WITH OCCURRENCE OF GRAFT KINKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172130 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03024699

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention