BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3071438 · Received April 22, 2013

    Report

    Report Number
    2953200-2013-00744
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (STENT GRAFT OCCLUSION, PARALYSIS, RENAL COMPLICATIONS); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (BLOOD CLOTTING DISORDER). CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (STENT GRAFT OCCLUSION, PARALYSIS, RENAL COMPLICATIONS); DEVICE FAILURE RELATED TO PATIENT CONDITION (BLOOD CLOTTING DISORDER).

    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. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNKNOWN. IT WAS REPORTED THAT THE PATIENT CAME IN FOR A FOLLOW UP APPOINTMENT TWO WEEKS POST IMPLANT. THE PATIENT WAS FEELING TIRED AND CONSTIPATED. THE PHYSICIAN CALLED IN A PRESCRIPTION AND THE PATIENT WENT DOWNSTAIRS TO PICK IT UP. WHILE GETTING THE MEDICATION THE PATIENT'S LEGS WENT NUMB AND THE PATIENT WAS EMERGENTLY TAKEN TO THE ER. A CT WAS PERFORMED AND NOTED THAT THERE WAS AN OCCLUSION. AN EMBOLECTOMY WAS PERFORMED THROUGHOUT THE STENT GRAFTS TO REMOVE CLOT AND THROMBUS. THE STENT GRAFTS WERE BALLOONED AND THE PROCEDURE WAS COMPLETE. THE NEXT DAY THE PATIENT HAD A COLD RIGHT LEG AND THE LEFT LEG WAS WARM. BLOOD WORK WAS ORDERED AND FOUND THAT THE PATIENT HAS A RARE BLOOD CLOT DISORDER (LUPUS COAGULANT DISORDER, POSITIVE PRO-THROMBIN FACTOR TO MUTATION). THE PATIENT IS CURRENTLY EXPERIENCING PARAPLEGIA AND IS ON DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171488 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03049221

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention