BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 3212705 · Received July 9, 2013

    Report

    Report Number
    2134265-2013-04676
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    December 8, 2011
    Report Date
    June 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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. THE BATCH NUMBER IS UNKNOWN; THEREFORE THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE CANNOT BE REVIEWED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(6) CLINICAL STUDY. SAME CASE AS 2134265-2013-04677. IT WAS REPORTED THAT POST STENTING PROCEDURE, THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION. IN (B)(6) 2011, THE PATIENT PRESENTED WITH STABLE ANGINA AND CARDIAC CATHETERIZATION WAS PERFORMED WHICH REVEALED THE TARGET LESION THAT WAS LOCATED IN THE 80% STENOSED MID RIGHT CORONARY ARTERY AND WAS 12MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 2.50 X 24MM TAXUS LIBERTÉ STENT WHICH RESULTED TO 0% RESIDUAL STENOSIS. DURING THE PROCEDURE, A NON-TARGET LESION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX WAS ALSO TREATED WITH THE PLACEMENT OF A 3.0 X 32MM ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. ON THE SAME DAY THAT THE PATIENT WAS DISCHARGED, THE PATIENT EXPERIENCED ANGINAL PAIN WAS DIAGNOSED WITH ARC MYOCARDIAL INFARCTION. AT THE TIME OF THE EVENT, THE PATIENT WAS TAKING ASPIRIN AND PRASUGREL. CARDIAC ENZYMES WERE ELEVATED, CONSISTENT WITH PROTOCOL DEFINITION OF MYOCARDIAL INFARCTION. THE PATIENT WAS TREATED WITH NITROGLYCERINE. ON THE SAME DAY, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314058 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK692

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization