BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2991570 · Received March 6, 2013

    Report

    Report Number
    2953200-2013-00417
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION CODES, RESULTS: INCORRECT TECHNIQUE/PROCEDURE (HELD THE GRAFT COVER DURING DEPLOYMENT INSTEAD OF THE FRONT GRIP OF THE DEPLOYMENT HANDLE); CAUSED BY ANOTHER DRUG/DEVICE (GLOVE). CONCLUSION: USER ERROR CONTRIBUTED TO EVENT (HELD THE GRAFT COVER DURING DEPLOYMENT INSTEAD OF THE FRONT GRIP OF THE DEPLOYMENT HANDLE); ANOTHER DEVICE CAUSED FAILURE (GLOVE).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. IT WAS REPORTED THAT THE PHYSICIAN'S GLOVE GOT CAUGHT IN THE STRAIN RELIEF DISTAL TO THE FRONT GRIP OF THE DELIVERY SYSTEM. THIS OCCURRED AS THE OUTER CATHETER WAS COMING BACK DURING DEPLOYMENT OF THE STENT GRAFT. THE PHYSICIAN NOTICED THE PROBLEM AND WAS ABLE TO GET THE GLOVE OUT. THE STENT GRAFT WAS SUCCESSFULLY DEPLOYED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. THE DEVICE WAS RETURNED BLOODIED. UPON INSPECTION, THE DEVICE WAS UNREMARKABLE. WHEN RECEIVED, THE EXTERNAL SLIDER HANDLE WAS 1 MM FROM THE FRONT GRIP, THE WHEEL WAS ROTATED FORWARD 9 MM AND THE TAPERED TIP WAS 10 MM FROM THE DISTAL EDGE OF THE GRAFT COVER. ONCE THE EXTERNAL SLIDER HANDLE AND THE WHEEL WERE RETURNED TO THEIR RESPECTIVE HOME POSITIONS, THE DISTANCE FROM THE TAPERED TIP TO THE GRAFT COVER WAS LESS THAN 1 MM. BOTH THE EXTERNAL SLIDER HANDLE AND WHEEL FUNCTIONED AS INTENDED. THE GRAFT COVER OD JUST DISTAL TO STRAIN RELIEF WAS 0.262 INCHES, WHICH IS WITHIN SPECIFICATION. THE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER WAS MOST LIKELY CAUSED BY THE PHYSICIAN GRABBING THE GRAFT COVER DURING DEPLOYMENT INSTEAD OF THE FRONT GRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95358 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03014749

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR