BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE OTW CORONARY STENT DEL SYS

    MDR report key: 772007 · Received October 19, 2006

    Report

    Report Number
    6000093-2006-02131
    Event Type
    Injury
    Date Received
    October 19, 2006
    Date of Event
    September 21, 2006
    Report Date
    September 22, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. SHOULD FURTHER RELEVANT INFO BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. THE MFG RECORDS FOR TOP ASSEMBLY BATCH 6973656 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THERE IS ONE OTHER COMPLAINT RELATED TO THIS BATCH NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PTCA AND STENTING PROCEDURE, WHILE ATTEMPTING TO CROSS A TORTUOUS VESSEL IN THE MID RIGHT CORONARY ARTERY (RCA), THE LIBERTE STENT CAME OFF THE BALLOON. THE STENT MIGRATED DOWN INTO THE DISTAL PORTION OF THE RCA. THE PHYSICIAN PERFORMED A CRUSHING TECHNIQUE. ANOTHER OF THE SAME DEVICES WAS USED SUCCESSFULLY, AND PT STATUS WAS REPORTED AS "OKAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE OTW CORONARY STENT DEL SYS CORONARY STENT SYSTEM MAF BOSTON SCIENTIFIC 16MM X 3.5MM 6973656

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention