BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3102351 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03099
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 8, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS 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 RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, SIDE BRANCH STENOSIS INCREASED. IN (B)(6) 2013, THE PATIENT PRESENTED WITH UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION CLASSIFICATION-IIB) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 60% STENOSED, 32 X 2.75MM TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE TARGET LESION WAS TREATED WITH PRE-DILATATION, PLACEMENT OF A 3.00 X 38 MM STUDY STENT AND POST-DILATATION WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON DUAL ANTIPLATELET THERAPY. BASELINE CORE LAB ANGIOGRAPHY REVEALED 0% SIDE BRANCH STENOSIS IN THE 2ND DIAGONAL. POST PROCEDURE ANGIOGRAPHY REVEALED 70% 'BRANCH PERCENT STENOSIS' IN THE 2ND DIAGONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202959 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911438300 15347138

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other