BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2160348 · Received July 13, 2011

    Report

    Report Number
    2134265-2011-02658
    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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER. THE COMPLAINT DEVICE WAS NOT RECEIVED 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, A STENT DISLODGEMENT OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS, MILDLY CALCIFIED RIGHT CORONARY ARTERY (RCA), DISTAL TO THE PREVIOUSLY IMPLANTED 3.5X24MM ION STENT IN THE OSTIAL RCA. THE PHYSICIAN ATTEMPTED TO PLACE THE 3.5X16MM ION STENT, BUT WAS UNABLE CROSS THE PREVIOUSLY PLACED STENT. THE PHYSICIAN REMOVED THE STENT, GUIDE WIRE AND GUIDE CATHETER FROM THE BODY. IT WAS IDENTIFIED, OUTSIDE THE BODY, THAT THE STENT HAD BECOME DISLODGED FROM THE DELIVERY SYSTEM. THE UNDEPLOYED STENT WAS LOCATED IN THE MID RCA. AN ATTEMPT TO SNARE THE STENT WAS UNSUCCESSFUL. THE STENT WAS CRUSHED WITH 3.5X20MM NC QUANTUM APEX BALLOON. A 3.5X20MM ION STENT WAS SUCCESSFULLY DEPLOYED OVER THE CRUSHED 3.5X16MM ION STENT. A 4.0X8MM ION WAS DEPLOYED IN THE OSTIAL RCA TO TREAT A SEPARATE LESION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS 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 H7493902416350 14042626

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention KINETIX GUIDE WIRE