BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1935533 · Received November 8, 2010

    Report

    Report Number
    2953200-2010-02175
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 9, 2010
    Report Date
    October 13, 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). EVALUATION: RESULTS: STENT STRUT DISTURBED DUE TO USER HANDLING DURING PREP. DAMAGED STENT FLATTENED BY HAND AND THEN USED IN THE PATIENT. CONCLUSION: DEVICE FAILURE RELATED TO USER HANDLING; STENT STRUT DISTURBED DUE TO USER HANDLING DURING PREP. STENT DAMAGED DUE TO HANDLING AND SUBSEQUENTLY USED IN THE PATIENT.

    Description of Event or Problem · 1

    THE PHYSICIAN SUCCESSFULLY DEPLOYED A DRIVER SPRINT RAPID EXCHANGE 2.25 DIAMETER, 24 MM LENGTH STENT WAS ADVANCED TO A LESION IN THE LAD; HOWEVER, PRIOR TO INSERTION, THE STENT WAS DAMAGED DUE TO HANDLING. THERE WAS A RAISED STRUT THAT WAS FLATTENED BY A FINGER AND THE STENT WAS DEPLOYED IN THE PATIENT. NO PROBLEM WITH USE OF THE STENT. NO OTHER CLINICAL SEQUELAE HAVE BEEN REPORTED. PLEASE NOTE THAT THIS DEVICE (B)(4) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVER SPRINT RX CORONARY STENT SYSTEM MAF MEDTRONIC CARDIOVASCULAR GALWAY NA 0003192898

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK