BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2192815 · Received July 20, 2011

    Report

    Report Number
    9612164-2011-00771
    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 90% STENOSIS AND SOME CALCIFICATION. EVAL SUMMARY: THE DEVICE WAS RETURNED TO THE MFG FACILITY FOR EVAL. THE STENT WAS POSITIONED ON THE BALLOON BETWEEN THE MARKER BANDS AS PER SPECS. THE 8TH AND 9TH DISTAL STENT SEGMENTS WERE RAISED AND DEFORMED.

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO IMPLANT A 2.75 MM DIAMETER X 24 MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO TREAT A LESION IN THE MID LAD. THE TARGET LESION EXHIBITED 90% STENOSIS AND SOME CALCIFICATION. THE LESION WAS PRE-DILATED ONCE USING A 2.5 X 20 MM BALLOON UP TO 14 ATMS. THE STENT COULD NOT CROSS THE LESION AND THE DEVICE WAS REMOVED. STENT STRUTS WERE OBSERVED TO BE DAMAGED ON REMOVAL. THE TARGET LESION WAS TREATED USING ANOTHER BRAND STENT. 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 0005479127

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK