BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2192790 · Received July 20, 2011

    Report

    Report Number
    9612164-2011-00768
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 20, 2011
    Manufacturer
    MEDTRONIC IRELAND
    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): RESULTS/CONCLUSIONS: SEVERELY CALCIFIED LESION. EVAL SUMMARY: THE DEVICE WAS RETURNED FOR EVAL. STENT WAS POSITIONED ON THE BALLOON BETWEEN MARKER BANDS AS PER SPEC. THE DISTAL TIP WAS SLIGHTLY FRAYED INDICATING THAT IT MAY HAVE BEEN STUBBED DURING ADVANCEMENT. A NUMBER OF STRUTS ON THE 12TH AND 13TH PROXIMAL STENT SEGMENT WERE PARTIALLY RAISED AND DEFORMED. ONE STRUT ON THE 1ST DISTAL SEGMENT WAS RAISED. PLEASE NOTE THAT THIS DEVICE (B)(4) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO UNITED STATES DISTRIBUTED PRODUCT (B)(4).

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO USE A DRIVER SPRINT RAPID EXCHANGE CORONARY STENT SYSTEM DIAMETER 3MM LENGTH 30MM TO TREAT A SEVERELY CALCIFIED LESION IN THE PROXIMAL/MID LAD BY DIRECT STENTING. THE DEVICE FAILED TO CROSS THE LESION. THE PHYSICIAN PRE-DILATED THE LESION AND ATTEMPTED TO CROSS AGAIN. THIS WAS UNSUCCESSFUL. PHYSICIAN CONFIRMED THAT THE STENT STRUT WAS FLARED. PHYSICIAN THEN DECIDED TO USE A NON-MEDTRONIC STENT AND COMPLETED THE PROCEDURE. NO HEALTH HAZARD WAS CAUSED TO THE PT. NO ADD'L CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVER SPRINT RX CORONARY STENT SYSTEM MAF MEDTRONIC IRELAND NA 0005089193

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK