BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3073259 · Received April 23, 2013

    Report

    Report Number
    2134265-2013-02711
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    January 29, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 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

    SAME CASE AS MDR#2134265-2013-02710. (B)(4). IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH STENT IMPLANTATION SIDE BRANCH OCCLUSION OCCURRED. THE PATIENT PRESENTED DUE TO STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). IT WAS DESCRIBED AS 30MM LONG, WITH A VESSEL DIAMETER OF 2.25 MM AND 99% STENOSIS. THE ANGIOGRAPHY ALSO REVEALED 10% SIDE BRANCH STENOSIS AT 1ST SEPTAL. THE LAD LESION WAS TREATED WITH IMPLANTATION OF TWO PROMUS ELEMENT PLUS STENTS (2.25X28 MM AND 2.25X12MM), WITH 0% RESIDUAL STENOSIS. POST PROCEDURE ANGIOGRAPHY REVEALED 80% 'BRANCH STENOSIS' IN 1ST SEPTAL. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON DUAL ANTIPLATELET THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174291 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911428220 0015532483

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other