BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1884870 · Received October 15, 2010

    Report

    Report Number
    2953200-2010-01971
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. STENT DAMAGE REPORTED TO HAVE BEEN NOTED PRIOR TO USE, STENT CONTINUED TO BE USED IN PROCEDURE. CONCLUSIONS: ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. DEVICE EVAL: THE STENT WAS POSITIONED ON THE BALLOON AS PER SPECIFICATION. A NUMBER OF STRUTS ON THE 6TH PROXIMAL STENT SEGMENT WERE SLIGHTLY RAISED AND DEFORMED. THERE WERE GAPS EVIDENT BETWEEN THE 7TH AND 8TH PROXIMAL STENT SEGMENT.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO DELIVER A 2.25MM DIAMETER X 12MM LENGTH DRIVER SPRINT RX CORONARY STENT TO A LESION IN THE LCX. THE LESION WAS REPORTED TO EXHIBIT 99% STENOSIS, MODERATE TORTUOSITY AND SEVERE CALCIFICATION. THE LESION WAS PRE-DILATED FIVE TIMES UP TO 8ATM'S. AT 90% STENOSIS REMAINED FOLLOWING THE PRE-DILATATION ACTIVITIES. THE PHYSICIAN FELT RESISTANCE WHILE ATTEMPTING TO DELIVER THE DRIVER SPRINT STENT AND SO, THE DEVICE WAS REMOVED. UPON REMOVAL, THE PHYSICIAN NOTED DEFORMATION OF THE STENT. THE PHYSICIAN ALSO REPORTED THAT STENT DEFORMATION HAD BEEN NOTED PRIOR TO USE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW DRSP22512X. NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVER SPRINT RX CORONARY STENT SYSTEM MAF MEDTRONIC CARDIOVASCULAR GALWAY NA 0003447566

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR