BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3429710 · Received October 25, 2013

    Report

    Report Number
    2953200-2013-02085
    Event Type
    Injury
    Date Received
    October 25, 2013
    Date of Event
    September 27, 2013
    Report Date
    September 27, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ENDOLEAK, INACCURATE DELIVERY. ANGLED LONG NECK THAT MEASURED 29-32MM. USER RELATED; STENT GRAFT UNDERSIZED. CONCLUSION: ENDOLEAK, INACCURATE DELIVERY. ANGLED LONG NECK THAT MEASURED 29-32MM. USER RELATED; STENT GRAFT UNDERSIZED.

    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. THE PATIENT HAD AN ANGLED LONG NECK THAT MEASURED 29-32MM. IT WAS REPORTED AT THAT ANOTHER MANUFACTURER¿S STENT GRAFT WAS ATTEMPTED FIRST; HOWEVER, THE DEVICE DID NOT GO UP DUE TO THE ANATOMY. THE DEVICE WAS SUCCESSFULLY REMOVED. THE ENDURANT 3214102 WAS IMPLANTED; HOWEVER AFTER PLACEMENT THERE WAS A STRONG PROXIMAL TYPE 1 ENDOLEAK. THE AORTIC NECK APPEARED TO MEASURE 32 CAUSING THE DEVICE TO BE INACCURATELY DELIVERED, SLIPPING DOWN 1 CM, RESULTING IN THE TYPE I ENDOLEAK. AN ENDURANT 3614102 WAS SUCCESSFULLY IMPLANTED TO TREAT THE ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548672 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04079153

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Required Intervention