BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3222542 · Received July 12, 2013

    Report

    Report Number
    2134265-2013-04838
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    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 RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT SUBSEQUENT TO A CORONARY STENTING TREATMENT PROCEDURE, PATIENT EXPERIENCED ANGINA AND TARGET VESSEL REVASCULARIZATION OCCURRED. IN (B)(6) 2012, THE SUBJECT PRESENTED DUE TO UNSTABLE ANGINA AND UNDERWENT CARDIAC CATHETERIZATION WHICH REVEALED A DE NOVO LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH 80% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3 MM. IT WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 MM X 12 MM PE PLUS STENT, WITH 0% RESIDUAL STENOSIS. THE NEXT DAY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2013, THE SUBJECT PRESENTED WITH ANGINA AND WAS HOSPITALIZED ON THE SAME DAY. THE SUBJECT UNDERWENT CARDIAC CATHETERIZATION WHICH REVEALED A 90% STENOSIS LOCATED IN MID RCA JUST BEFORE THE PREVIOUSLY PLACED STUDY STENT. IT WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF 3 X 12 MM NON-BSC STENT WITH 0% RESIDUAL STENOSIS. THE NEXT DAY, THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED ON ASPIRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323790 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911412300 15076305

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R