BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3903153 · Received June 30, 2014

    Report

    Report Number
    2953200-2014-01314
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 15, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. IT WAS REPORTED THAT THE PATIENT INQUIRED ABOUT DEVICE REJECTION AND IF THIS COULD OCCUR. THE PATIENT WAS NOTIFIED THAT INTRODUCING A FOREIGN OBJECT TO THE BODY ALWAYS HAS THE POTENTIAL FOR REJECTION AND BECAUSE OF THIS IT IS HIGHLY IMPORTANT TO COMMUNICATION WITH THEIR PHYSICIAN AND ALERT THEM IF THEY EXPERIENCE ANYTHING OUT OF THE ORDINARY. THE PATIENT NOTED THE NEXT APPOINTMENT WAS ALREADY SCHEDULED. THE PATIENT WENT ON TO MENTION THAT FOLLOWING THE STENT GRAFT IMPLANT THEY HAVE BEEN EXPERIENCING STOMACH PROBLEMS (FEELS FULL AND BLOATED AT ALL TIMES AND IS NOT EXPERIENCING REGULAR BOWEL MOVEMENTS). THE PATIENT IS IN CONTACT WITH THEIR PRIMARY CARE PHYSICIAN. NO FURTHER INFORMATION IS AVAILABLE AND NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380889 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04155241

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR