BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3854562 · Received June 6, 2014

    Report

    Report Number
    2953200-2014-01159
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED INTO A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS NOT REPORTED AS THIS WAS AN EMERGENT CASE. IT WAS REPORTED THAT THE PATIENT WAS IN AFIB, PER THE ANAESTHESIOLOGIST PRIOR TO THE INSERTION OF THE STENT GRAFT DELIVERY SYSTEM. THE PHYSICIAN WAS NOT NOTIFIED ABOUT THE AFIB UNTIL THE FOLLOWING DAY. IT WAS REPORTED THAT THE PATIENT MAY HAVE HAD A TIA HOWEVER THE TEST THAT WERE DONE DID NOT REVEAL ANY ISSUES. THE PATIENT WAS GIVEN ANTICOAGULANTS AND ACCORDING TO THE PHYSICIAN, THE PATIENT MADE A COMPLETE RECOVERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331984 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04207908

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention