BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION¿

    MDR report key: 2637446 · Received July 2, 2012

    Report

    Report Number
    2134265-2012-03859
    Event Type
    Injury
    Date Received
    July 2, 2012
    Date of Event
    May 25, 2012
    Report Date
    June 6, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). 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. 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)(6) CLINICAL TRIAL. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, ANGINA AND IN-STENT RESTENOSIS OCCURRED. (B)(6) 2012 - THE PATIENT PRESENTED WITH STABLE ANGINA. THE 80% STENOSED, 15MM LONG TARGET LESION WAS LOCATED IN THE MID LAD, DISTAL TO THE PREVIOUSLY PLACED STENTS, WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.50 MM X 20 MM ION US COA STENT WITH 0% RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED THE NEXT DAY ON CLOPIDOGREL. (B)(6) 2012 - THE PATIENT PRESENTED WITH ANGINA. CORONARY ANGIOGRAPHY REVEALED DIFFUSE IN-STENT RESTENOSIS (ISR) WITH A 99% END-STENT STENOSIS IN THE MID LAD. THE ISR WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF TWO NON-BSC DRUG ELUTING STENTS, 2.5 X 26MM AND 2.5 X 12MM, WITH 10% RESIDUAL STENOSIS. TWO DAYS LATER THE EVENT WAS CONSIDERED RESOLVED WITHOUT ANY RESIDUAL EFFECTS. THE PATIENT WAS ON ASPIRIN AND CLOPIDOGREL AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902420250 14759293

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R