BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2192814 · Received July 20, 2011

    Report

    Report Number
    9612164-2011-00772
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: STENT DAMAGE, FAILURE TO DELIVER THE STENT. RESULTS/CONCLUSIONS: TARGET LESION EXHIBITED 85% STENOSIS FOLLOWING PRE-DILATION, MODERATE CALCIFICATION AND MODERATE TORTUOSITY. USE OF FORCE. EVAL SUMMARY: THE DEVICE WAS RETURNED TO THE MFG FACILITY FOR EVAL. THE STENT WAS POSITIONED BETWEEN THE MARKER BANDS AS PER SPECS. THE 5TH AND 6TH PROXIMAL STENT SEGMENTS WERE RAISED, DEFORMED AND PULLED DISTALLY.

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO IMPLANT A 2.5 MM DIAMETER X 18 MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO TREAT A LESION IN THE LCX. THE TARGET LESION EXHIBITED 90% STENOSIS, MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE LESION WAS PRE-DILATED TWICE USING A 1.5 X 12 MM SPRINTER BALLOON UP TO 10 ATMS. EIGHTY-FIVE PERCENT STENOSIS REMAINED FOLLOWING PRE-DILATION. THE ENDEAVOR SPRINT STENT COULD NOT CROSS THE LESION AND THE DEVICE WAS REMOVED. FORCE WAS USED IN THE ATTEMPT TO ADVANCE THE DEVICE TO THE TARGET LESION. STENT STRUTS WERE OBSERVED TO BE DAMAGED ON REMOVAL. THE TARGET LESION WAS TREATED USING ANOTHER ENDEAVOR STENT OF THE SAME SIZE. THE DEVICE HAD BEEN INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED. PT STATUS POST PROCEDURE WAS STABLE AND NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0005417454

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK