BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3951309 · Received July 22, 2014

    Report

    Report Number
    2953200-2014-01437
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, CONCLUSION: OFF-LABEL, UNAPPROVED OR CONTRAINDICATED USE (AORTIC NECK ANGLE > 60 DEGREES).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 58 X 85 MM ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK DIAMETER WAS 18.3 MM WITH A LENGTH OF 41 MM. THE AORTIC NECK ANGULATION WAS 80 DEGREES. THE PROXIMAL NECK HAD TWO SEVERE AREAS OF TORTUOSITY; THEREFORE, AFTER THE STENT GRAFT WAS DEPLOYED THE DELIVERY SYSTEM WAS UNABLE TO BE REMOVED BY PULLING. THE DELIVERY SYSTEM WAS ADVANCED CLOSE TO THE DESCENDING AORTA TO RETRACT/DOCK THE SPINDLE INTO THE GRAFT COVER AND THEN IT WAS REMOVED FROM THE PATIENT. THERE WAS A PROXIMAL TYPE I ENDOLEAK NOTED. THE PROCEDURE WAS COMPLETED WITH IMPLANT OF ANOTHER MANUFACTURER¿S STENT GRAFT WHICH WAS DEPLOYED FROM THE EXTERNAL ILIAC ARTERY OF THE ENDURANT IPSILATERAL LIMB. THE TYPE IA ENDOLEAK REMAINED AND THE PATIENT WILL BE MONITORED BY THE PHYSICIAN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. THE PHYSICIAN COMMENTED THAT THERE WOULD HAVE BEEN THE SAME RESULT WITH THE ENDOLEAK AS WITH ANY OTHER DEVICE THAT WOULD HAVE BEEN IMPLANTED. THE USE OF THE ENDURANT LED TO A SMALL ENDOLEAK THAT WOULD RESOLVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428637 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04251155

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention