BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2181598 · Received July 6, 2011

    Report

    Report Number
    9612164-2011-00674
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 8, 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

    EVALUATION SUMMARY: THE STENT WAS POSITIONED ON THE BALLOON BETWEEN THE MARKER BANDS AS PER SPECIFICATIONS. THE 4TH PROXIMAL STENT SEGMENT WAS RAISED, DEFORMED AND PULLED DISTALLY. A NUMBER OF OTHER SEGMENTS WERE SLIGHTLY RAISED AND MISALIGNED. (B)(4). EVALUATION, RESULTS: (MODERATE CALCIFICATION. 85% STENOSIS), (STENT DAMAGE, FAILURE TO DELIVER THE STENT). CONCLUSIONS: (MODERATE CALCIFICATION. 85% STENOSIS).

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO IMPLANT A 2.5 MM DIAMETER X 30 MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO TREAT A LESION IN THE RCA WITH MODERATE CALCIFICATION AND 85% STENOSIS. THE TARGET LESION WAS PRE-DILATED TWICE UP TO 12 ATM'S. THE STENT COULD NOT CROSS THE LESION AND THE DEVICE WAS REMOVED. STENT STRUTS WERE OBSERVED TO BE DAMAGED ON REMOVAL. 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 0004716323

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK