BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II

    MDR report key: 4260196 · Received November 18, 2014

    Report

    Report Number
    2953200-2014-02424
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Date of Event
    November 12, 2014
    Report Date
    November 12, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, CONCLUSION: OFF-LABEL (NECK ANGULATION GREATER THAN 60 DEGREE, NECK LENGTH LESS THAN 10MM).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 6 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK WAS 23 MM IN DIAMETER AND 7MM IN LENGTH. THE LEFT COMMON ILIAC ARTERY WAS 9 MM IN DIAMETER AND THE RIGHT COMMON ILIAC ARTERY WAS 20 MM IN DIAMETER. THE RIGHT AND LEFT EXTERNAL ILIAC ARTERIES MEASURED 7.6 MM IN DIAMETER. THE AORTIC NECK ANGULATION WAS 70 DEGREES. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE BIFURCATE WAS INSERTED FROM THE RIGHT SIDE HOWEVER, THE PHYSICIAN HAD DIFFICULTY IN LANDING TO THE GREATER CURVATURE OF PROXIMAL NECK. SO, THE MAIN BODY WAS INSERTED FROM LEFT SIDE. THERE WAS NO SUFFICIENT SEALING SPACE, BUT THE STENT GRAFT WAS SUCCESSFULLY DEPLOYED WITH PUSH-UP. INITIAL TOUCH-UP WAS NOT CARRIED OUT AS THE PROXIMAL AORTIC NECK DIDN¿T HAVE ENOUGH TOUCH-UP SPACE. ON THE FINAL ANGIOGRAM, A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED SO THE PHYSICIAN BALLOONED HOWEVER, THE ENDOLEAK REMAINED. THE PHYSICIAN COMMENTED THAT ¿IT WAS QUITE A DIFFICULT CASE. IN CASE OF NORMAL CASE, OPEN SURGERY WOULD BE PERFORMED. BUT THE PATIENT HAD OPEN SURGERY IN THE PAST SO THAT ANOTHER OPEN SURGERY SHOULD BE AVOIDED.¿ NO ADDITIONAL TREATMENT IS PLANNED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746182 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V05904373

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR