BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2831699 · Received November 14, 2012

    Report

    Report Number
    2134265-2012-07052
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    February 14, 2012
    Report Date
    October 16, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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). IT WAS REPORTED THAT POST CORONARY STENTING PROCEDURE, TARGET VESSEL REVASCULARIZATION OCCURRED IN (B)(6) 2008, THE SUBJECT PRESENTED WITH COMPLAINTS OF CHEST PAIN AND WAS SUBSEQUENTLY DIAGNOSED AS STABLE ANGINA (CCS CLASS-3). CARDIAC CATHETERIZATION WAS RECOMMENDED WHICH REVEALED AN 80% STENOSED LESION LOCATED IN THE 1ST RIGHT POSTEROLATERAL (RPL) SEGMENT. THE LESION WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM AND TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 16 MM STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0% AND THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL TWO DAYS LATER. IN (B)(6) 2012, THE SUBJECT PRESENTED WITH COMPLAINTS OF CHEST PAIN AND SHORTNESS OF BREATH. CARDIAC CATHETERIZATION WAS RECOMMENDED WHICH REVEALED A 77% STENOSED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND WAS TREATED WITH PLACEMENT OF A 4.0 X 18 MM NON-BSC BARE METAL STENT. DURING THE COURSE OF HOSPITALIZATION SUBJECT EXPERIENCED ATRIAL FIBRILLATION, PNEUMONIA, SYSTOLIC HEART FAILURE, AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE WHICH WAS TREATED MEDICALLY. THE PNEUMONIA, SYSTOLIC HEART FAILURE, AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE WERE CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED. IN (B)(6) 2012, THE ATRIAL FIBRILLATION 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 11068829

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| O