BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2230445 · Received September 1, 2011

    Report

    Report Number
    2134265-2011-03616
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION STENT DAMAGED OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO CROSS AN 8 X 2.5MM ION MONORAIL DRUG-ELUTING STENT THROUGH A PREVIOUSLY PLACED STENT. AFTER REMOVING THE DEVICE IT WAS OBSERVED THAT THE STENT STRUTS FLARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902408220 14142027

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR