BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2823150 · Received November 7, 2012

    Report

    Report Number
    2134265-2012-06663
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    September 9, 2011
    Report Date
    October 9, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(6). DEVICE EVALUATED BY MANUFACTURER - 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

    (B)(4). SAME CASE AS: 2134265-2012-06664. SAME PATIENT AS: 2134265-2008-02949. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED STENOSIS. IN (B)(6) 2008, THE PATIENT WAS DIAGNOSED WITH STABLE ANGINA (CCS CLASSIFICATION:2) AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS 80% STENOSED, 2.25MM IN DIAMETER AND 6MM LONG. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.25X12MM STUDY STENT. POST DILATION WAS PERFORMED. A GRADE B DISSECTION WAS NOTED. THIS DISSECTION WAS TREATED WITH A BAILOUT 2.25X8MM STUDY STENT. RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH CORONARY ARTERY DISEASE. CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 80% STENOSIS LOCATED IN THE MID LAD AND 1ST DIAGONAL WAS TREATED WITH CUTTING BALLOON ANGIOPLASTY AND PLACEMENT OF A NON-BSC STENT. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS.

    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 11519081

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention