BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2181773 · Received July 27, 2011

    Report

    Report Number
    2134265-2011-03081
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR:THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE 80% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE MODERATE TO SEVERELY CALCIFIED AND MODERATE TO SEVERELY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH A 3.0X10MM CUTTING BALLOON. A 3.50X38MM ION STENT DELIVERY SYSTEM (SDS) WAS THEN ADVANCED TO THE RCA AND SUCCESSFULLY DEPLOYED. A 4.00X38MM ION SDS WAS THEN ADVANCED WITH THE INTENTION OF PLACING THE STENT PROXIMALLY TO THE 3.50X38MM ION, HOWEVER THE PHYSICIAN EXPERIENCED RESISTANCE IN THE PATIENT ANATOMY AND WITHDREW THE DEVICE. UPON REMOVAL IT WAS NOTED THAT THE DISTAL END OF THE STENT WAS FLARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.50X38MM ION DEVICE PLACED PROXIMALLY TO THE PREVIOUSLY DEPLOYED STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    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 H7493902438400 14210158

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR