BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2161670 · Received July 14, 2011

    Report

    Report Number
    2134265-2011-02706
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Report Date
    June 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE OSTIAL SAPHENOUS VEIN GRAFT. THE PHYSICIAN DEPLOYED THE ION STENT. THE STENT APPEARED TO BE CRUMPLED/ACCORDIONED BY IT'S SELF AT THE OSTIUM. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION 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 UNK692

    Patients

    Seq Age Sex Outcome Treatment
    1