BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3252047 · Received July 29, 2013

    Report

    Report Number
    2953200-2013-01458
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS AND CONCLUSION: (ENDOLEAK). (SHORT AND ANGULATED AORTIC NECK). (AORTIC NECK LENGTH LESS THAN 10MM).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 8 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS SHORT MEASURING 8 ¿ 10 MM IN LENGTH AND IT WAS HIGHLY ANGULATED. THE STENT GRAFTS WERE IMPLANTED ON AN EMERGENCY BASIS AS THE PATIENT HAD A LARGE ANEURYSM. IT WAS REPORTED THAT AFTER THE STENT GRAFTS WERE IMPLANTED THERE WAS A SMALL PROXIMAL TYPE I ENDOLEAK PRESENT. THE ENDOLEAK WAS ATTRIBUTED TO THE SHORT AND ANGULATED AORTIC NECK. THE AORTIC NECK WAS BALLOONED TWO TIMES AND THIS SLIGHTLY IMPROVED THE ENDOLEAK; HOWEVER, THE ENDOLEAK WAS STILL PRESENT. THERE WAS NOT ENOUGH ROOM TO PLACE A CUFF DUE TO THE SHORT AORTIC NECK. THE PHYSICIAN MADE THE DECISION TO NOT FURTHER INTERVENE AND TO MONITOR THE PATIENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353827 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03031518

    Patients

    Seq Age Sex Outcome Treatment
    1