BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2191538 · Received July 20, 2011

    Report

    Report Number
    9612164-2011-00774
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 22, 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). EVAL: RESULTS: STENT DAMAGE, FAILURE TO DELIVER THE STENT. RESULTS/CONCLUSIONS: TARGET LESION EXHIBITED MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 85% STENOSIS FOLLOWING PRE-DILATION. DEVICE EVAL: THE DEVICE WAS RETURNED TO THE MFG FACILITY FOR EVAL. THE STENT WAS POSITIONED ON THE BALLOON BETWEEN MARKER BANDS AS PER SPECS. THE 6TH PROXIMAL STENT SEGMENT WAS RAISED, DEFORMED AND PULLED DISTALLY. THE DISTAL TIP WAS SEVERELY STRETCHED. THE DISTAL END OF THE PROTECTIVE SHEATH WAS BUNCHED OVER THE DISTAL END OF THE STYLETTE.

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO IMPLANT A 2.75 MM DIAMETER X 18 MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO TREAT A LESION IN THE RCA. THE TARGET LESION EXHIBITED 90% STENOSIS, MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE LESION WAS PRE-DILATED TWICE USING A 2.0 X 15 MM BALLOON UP TO 14 ATMS. EIGHTY-FIVE PERCENT STENOSIS REMAINED FOLLOWING PRE-DILATION. THE ENDEAVOR SPRINT STENT COULD NOT CROSS THE LESION AND THE DEVICE WAS REMOVED. STENT STRUTS WERE OBSERVED TO BE DAMAGED ON REMOVAL. THE DEVICE HAD BEEN INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE TARGET LESION WAS TREATED USING AN ENDEAVOR STENT OF THE SAME SIZE. PT STATUS POST PROCEDURE WAS REPORTED AS 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 0005482254

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK