BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3000576 · Received March 12, 2013

    Report

    Report Number
    2953200-2013-00441
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (IRREGULARLY SHAPED AORTIC NECK). EVALUATION CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (IRREGULARLY SHAPED AORTIC NECK).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6-7 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY THREE WEEKS AGO. THE AORTIC NECK DIAMETER WAS 30MM TO 40MM TO 29MM FORM PROXIMAL TO DISTAL (PEANUT IN SHAPE). IT WAS REPORTED THAT THE STENT GRAFTS WERE SUCCESSFULLY IMPLANTED. THE BIFURCATED STENT GRAFT WAS PLACED AT THE LOWEST RENAL ARTERY. DUE TO THE PATIENT'S HIGH CREATININE LEVELS A NON-CONTRAST CT WAS DONE PRE-IMPLANT. THE FINAL ANGIOGRAM SHOWED A SMALL TYPE I ENDOLEAK. THE PHYSICIAN BELIEVES THAT THE ENDOLEAK WILL RESOLVE AND NO INTERVENTION WAS PERFORMED. THE PHYSICIAN WILL MONITOR THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102820 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00968475

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR