BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3781455 · Received April 30, 2014

    Report

    Report Number
    2134265-2014-02266
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 4, 2014
    Report Date
    April 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 IN-STENT RESTENOSIS (ISR) AND CHEST PAIN OCCURRED. ON (B)(6) 2012, THE PATIENT PRESENTED DUE TO STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 90% STENOSIS AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 X 12 MM PROMUS ELEMENT PLUS STENT, FOLLOWING POST DILATION WITH 0% RESIDUAL STENOSIS. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2014, THE PATIENT EXPERIENCED CHEST PAIN. THREE DAYS FROM THE ONSET OF SYMPTOMS, THE PATIENT WAS HOSPITALIZED AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 95% IN-STENT RESTENOSIS OF THE PROXIMAL LAD WAS TREATED WITH PERCUTANEOUS CORONARY INTERVENTION, WITH 0% RESIDUAL STENOSIS. ON THE SAME DAY, THE EVENT WAS CONSIDERED AS RESOLVED. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260910 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911412300 15450169

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R