BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3113496 · Received May 15, 2013

    Report

    Report Number
    2134265-2013-03388
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 14, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. 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) STUDY. IT WAS REPORTED THAT POST CORONARY STENTING TREATMENT PROCEDURE, ACUTE CHRONIC CONGESTIVE HEART FAILURE OCCURRED. IN (B)(6) 2012, THE SUBJECT PRESENTED MYOCARDIAL INFARCTION AND UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. IT REVEALED ONE TARGET LESION. THE LESION WAS LOCATED IN THE MIDDLE LEFT ANTERIOR DESCENDING ARTERY WITH 99% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE LESION WAS TREATED WITH DIRECT PLACEMENT USING A 3.0 MM X 12 MM PROMUS ELEMENT PLUS STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0 %. THE SUBJECT WAS DISCHARGED WITH ASPIRIN AND PRASUGREL. IN (B)(6) 2013, THE SUBJECT EXPERIENCED ACUTE CHRONIC CONGESTIVE HEART FAILURE AND WAS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215499 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911412300 15093264

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization