BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2150423 · Received June 7, 2011

    Report

    Report Number
    9612164-2011-00534
    Event Type
    Malfunction
    Date Received
    June 7, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 12, 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). EVALUATION, RESULTS: (STENT DAMAGE, FAILURE TO DELIVER THE STENT). RESULTS AND CONCLUSIONS: (MODERATELY CALCIFIED LESION WITH 90% STENOSIS FOLLOWING PRE-DILATION), (USE OF FORCE). EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THE DISTAL TIP WAS SLIGHTLY FRAYED. THE STENT WAS POSITIONED ON THE BALLOON BETWEEN MARKER BANDS AS PER SPECIFICATION. A NUMBER OF STRUTS ON THE 8TH AND 9TH PROXIMAL STENT SEGMENTS WERE RAISED AND PULLED DISTALLY.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING 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 LAD WITH MODERATED CALCIFICATION AND 95% STENOSIS. THE LESION WAS PRE-DILATED TWICE USING A 1.5 X 15 MM SPRINTER BALLOON UP TO 12 ATM'S. NINETY PERCENT STENOSIS REMAINED FOLLOWING PRE-DILATION. THE ENDEAVOR SPRINT COULD NOT CROSS THE LESION AND DAMAGE TO THE STENT STRUTS WAS OBSERVED ON REMOVAL. FORCE WAS USED IN AN EFFORT TO ADVANCE THE DEVICE TO THE TARGET LESION. THE DEVICE HAD BEEN INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED. THE TARGET LESION WAS TREATED USING ANOTHER ENDEAVOR STENT OF THE SAME SIZE. PATIENT 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 0005479131

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK