BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NG PROMUS

    MDR report key: 3072863 · Received April 23, 2013

    Report

    Report Number
    2134265-2013-02459
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    December 13, 2012
    Report Date
    March 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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. 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, SIDE BRANCH STENOSIS WAS NOTED. IN (B)(6) 2012, CLINICAL STATUS ASSESSMENT IDENTIFIED THE PATIENT'S QUALIFYING CONDITION AS UNSTABLE ANGINA (CCS CLASS II) AS WELL AS ABNORMAL FRACTIONAL FLOW RESERVE (FFR) INDICATING ISCHEMIA PRIOR TO THE PROCEDURE. THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MID LAD) WITH 50% STENOSIS AND WAS 10MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 2.50X20MM NG PROMUS STENT, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. THE CORE LAB REPORTED 0% SIDE BRANCH STENOSIS PER THE BASELINE INDEX ANGIOGRAPHY AND 70% SIDE BRANCH STENOSIS PER THE POST-PROCEDURE ANGIOGRAPHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175205 NG PROMUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493925020250 15490100

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other