BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2143360 · Received June 29, 2011

    Report

    Report Number
    2134265-2011-02725
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Report Date
    June 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2011-02469. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE 80% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE NON-TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PRE-DILATED WITH A 4.0X15MM NC QUANTUM APEX BALLOON. A 3.5X16MM ION AND A 4.0X16MM ION STENT DELIVERY SYSTEM WERE ADVANCED TO THE LAD AND DEPLOYED IN THE LESION. THE STENTS WERE NOT FULLY APPOSED TO THE VESSEL WALL SO POST-DILATION WITH A 4.0X15MM NON-COMPLIANT QUANTUM APEX BALLOON WAS PERFORMED. IT WAS NOTED THAT THE STENTS SHORTENED ABOUT 2 TO 3MM AFTER POST-DILATION. THE PHYSICIAN CONFIRMED THE SHORTENING WITH INTRAVASCULAR ULTRASOUND. THE PROCEDURE WAS COMPLETED AT THIS POINT. 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 UNK692

    Patients

    Seq Age Sex Outcome Treatment
    1 4.0 X15 NC QUANTUM APEX BALLOON CATHETER