BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2161431 · Received July 13, 2011

    Report

    Report Number
    2134265-2011-02805
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: 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 STENTING TREATMENT PROCEDURE STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY (RCA). A 4.00X28MM ION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE RCA; HOWEVER, DURING ADVANCEMENT, THE DEVICE BECAME CAUGHT UP ON THE CALCIUM IN THE LESION AND THE STENT DISLODGED FROM THE SDS. THE DISLODGED STENT REMAINED ON THE GUIDE WIRE AND THE PHYSICIAN WAS ABLE TO PULL THE DEVICE BACK IN THE GUIDE CATHETER. THE SYSTEM WAS THEN BACKED INTO THE AORTA AND FROM THAT POINT THE PHYSICIAN USED A SNARE TO REMOVE THE STENT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS STABLE.

    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 H7493902428400 14074560

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention