BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3140257 · Received May 31, 2013

    Report

    Report Number
    2953200-2013-01038
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 7, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (STENT GRAFT OCCLUSION); PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (MEDICATION CHANGE); CAUSED BY ANOTHER DRUG/DEVICE (MEDICATION CHANGE). CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (STENT GRAFT OCCLUSION); DEVICE FAILURE RELATED TO PATIENT CONDITION (MEDICATION CHANGE).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 47.3 MM IN DIAMETER ABDOMINAL AORTIC A NEURYSM. THE PROXIMAL NECK WAS 23.1 MM IN DIAMETER. IT WAS REPORTED THAT ON AN UNKNOWN DATE (APPROXIMATELY 6 MONTHS AGO), THE PATIENT WAS HOSPITALIZED FOR HEPATITIS AND THE PATIENT¿S ANTI-COAGULANT THERAPY WAS DISCONTINUED DURING THAT ADMISSION. THE PATIENT CURRENTLY PRESENTED WITH CLAUDICATION. A STUDY DONE IN THE PHYSICIAN OFFICE DETERMINED THE LEFT LIMB OF THE STENT GRAFT TO BE OCCLUDED ( CONTRALATERAL LIMB). THE PHYSICIAN DID NOT FEEL THAT THIS WAS LIMB THREATENING. THE PHYSICIAN DECIDED TO TREAT THE PATIENT WITH A FEMORAL-FEMORAL BYPASS SINCE THE OCCLUSION IS LIKELY CHRONIC, SINCE THE TIME ANTICOAGULATION WAS STOPPED 6 MONTHS AGO. THE PATIENT HAS NOT BEEN TREATED TO DATE AND THE PROCEDURE HAS NOT BEEN SCHEDULED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. A REVIEW OF A DRAWING SHOWED THAT THE LEFT LIMB WAS COMPLETELY OCCLUDED BEGINNING AT THE FLOW DIVIDER. THE CURRENT AAA SIZE IS 5.1CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242357 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01075361

    Patients

    Seq Age Sex Outcome Treatment
    1