BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2933521 · Received January 29, 2013

    Report

    Report Number
    2134265-2013-00274
    Event Type
    Injury
    Date Received
    January 29, 2013
    Report Date
    December 31, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE - 'A COUPLE WEEKS AGO'. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER -THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, A STENT OCCLUSION OCCURRED. IN (B)(6) 2011, A 2.5X20MM ION STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY). "A COUPLE WEEKS AGO" THE PHYSICIAN IDENTIFIED THE ION STENT WAS TOTALLY OCCLUDED AT THE PROXIMAL END NEAR THE LEFT MAIN. THE PATIENT WAS SENT TO SURGERY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38930 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 Required Intervention