BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2102390 · Received May 20, 2011

    Report

    Report Number
    2953200-2011-01032
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: CATHETER BREAKAGE, UNKNOWN CAUSE OF EVENT. CONCLUSIONS: UNKNOWN CAUSE OF EVENT. FILM EVALUATION: REVIEW OF RETURNED STILL IMAGES AND PHOTO COULD NOT CONFIRM HOW THIS EVENT COULD HAVE HAPPENED; OTHER THAN POSSIBLY SHIPPING OR SITE DAMAGE. TWO STILL IMPLANT ANGIOGRAM IMAGES SHOWED LITTLE ILIAC TORTUOSITY. EVALUATION SUMMARY: THE BROKEN SCREW GEAR WITH WHEEL WAS RETURNED COMPLETELY DETACHED FROM THE BACK END. THE SLIDER WAS RETRACTED 7MM. THE SPINDLE WAS NOT RECAPTURED INTO THE SLEEVE. THE TAPER TIP WAS NOT COMPLETELY RECAPTURED INTO THE GRAFT COVER BY 6MM. THERE WERE MINOR KINKS HALF WAY ON THE GRAFT COVER. THE INNER MEMBER HAD MINOR KINK/BEND 25MM DISTAL TO THE STINT STOP. DURING EVALUATION, THE DETACHED PART WAS DISASSEMBLED AND NO ABNORMALITIES WERE FOUND WITH THE INNER COMPONENTS. THERE WERE NO MANUFACTURING ISSUES IDENTIFIED AS CONTRIBUTING FACTORS TO THIS COMPLAINT AND A ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. DAMAGE MIGHT HAVE OCCURRED DURING SHIPPING OR HANDLING OF THE DEVICE, BUT IT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    AN ENDURANT BIFURCATED STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THERE WAS NO TORTUOSITY, AND MILD CALCIFICATION. IT WAS REPORTED THAT DURING THE TURNING OF THE BACK WHEEL TO DEPLOY THE SUPRARENAL STENT IT WAS NOTICED BY THE PHYSICIAN THAT THERE WAS A BREAK IN THE DISTAL END OF THE DELIVERY CATHETER. THE BREAK WAS BETWEEN THE BACK-END WHEEL AND THE SCREW GEAR REGION. THE SUPRARENAL STENT WAS DEPLOYED SUCCESSFULLY. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00818648

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK