BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2981652 · Received February 27, 2013

    Report

    Report Number
    2953200-2013-00348
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 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). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANGULATED AORTIC NECK). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANGULATED AORTIC NECK).

    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 APPROXIMATELY ONE MONTH AGO. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT A PROXIMAL TYPE I ENDOLEAK WAS PRESENT AFTER THE STENT GRAFT WAS IMPLANTED. THE PHYSICIAN BELIEVES THE ENDOLEAK WAS DUE TO THE CURVATURE OF THE AORTIC NECK. THE LOCATION OF THE ENDOLEAK WAS ON THE OUTER CURVATURE OF THE AORTIC NECK. AN ENDURANT AORTIC CUFF WAS IMPLANTED; HOWEVER, THE ENDOLEAK DID NOT COMPLETELY RESOLVE. THE PATIENT WILL BE MONITORED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83394 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1