BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2101059 · Received May 24, 2011

    Report

    Report Number
    2134265-2011-01855
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. PATIENT IDENTIFIER - (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 A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION. THE 90% STENOSED TARGET LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING(LAD) WAS 3.5MM DIAMETER AND 16MM LONG. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 3.5X20MM STUDY STENT. RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2011, THE PATIENT WAS ADMITTED WITH MYOCARDIAL INFARCTION (MI). ANGIOGRAPHY WAS PERFORMED BUT, NO REVASCULARIZATION DONE. THE LOCATION OF THE MI WAS REPORTED AS "NOT IDENTIFIABLE." THE PATIENT WAS DISCHARGED 1 DAY LATER.

    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 11068823

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other