BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3950303 · Received July 22, 2014

    Report

    Report Number
    2953200-2014-01434
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    July 2, 2014
    Report Date
    August 5, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCLUSION: UNABLE TO DETERMINE CAUSE.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED AND ITS EVALUATION HAS BEEN COMPLETED: THE EVENT WAS CONFIRMED; THE THUMBWHEEL WAS MISSING FROM THE DELIVERY SYSTEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED DURING ANALYSIS.

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6 CM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DEPLOYMENT OF THE BIFURCATED STENT GRAFT PROCEEDED AS USUAL UP TO THE RELEASE OF THE CONTRALATERAL LIMB. AS SOON AS THE PHYSICIAN PLACED THEIR FINGERS ON THE THUMBWHEEL TO RELEASE THE PROXIMAL SUPRA RENAL STENTS, THE THUMBWHEEL FELL OFF AND SEPARATED INTO TWO HALVES AND A SMALL THIRD PIECE. THE THUMBWHEEL COULD NOT BE SNAPPED BACK IN PLACE. THE PHYSICIAN CONTROLLED THE TOP CAP BY THE SMALL PLASTIC TAB UNDER THE THUMBWHEEL AND SLID IT FORWARD AND THEN SUBSEQUENTLY BACK ALONG THE BACK-END. THE BARE STENT WAS SUCCESSFULLY RELEASED; HOWEVER, DURING REMOVAL OF THE DEVICE THE PROTRUDING EDGE OF THE TOP CAP CAUGHT THE DISTAL PORTION OF THE IPSILATERAL LIMB AND CAUSED SOME DIFFICULTY REMOVING DELIVERY SYSTEM. AFTER SEVERAL ATTEMPTS TO MANIPULATE THE TOP CAP WITH THE PLASTIC TAB THE PHYSICIAN WAS ABLE TO REMOVE THE DELIVERY SYSTEM. LATER IN THE PROCEDURE, A DISSECTION WAS NOTICED IN THE COMMON ILIAC ARTERY AND THE PHYSICIAN AGREED THAT THE EXTRA MANIPULATION WHICH WAS NEEDED TO REMOVE THE DEVICE MAY HAVE CAUSED THE DISSECTION. THE PHYSICIAN DEPLOYED AN ADDITIONAL ENDURANT 16/16/82 TO TREAT THE DISSECTION IN THE COMMON ILIAC ARTERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH DEPLOYMENT OF CONTRALATERAL LIMBS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429127 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03997868

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention