BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3232980 · Received July 18, 2013

    Report

    Report Number
    2134265-2013-05061
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 16, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MDR ID 2134265-2013-05060. IT WAS REPORTED THAT POST A PERCUTANEOUS CORONARY INTERVENTION, ANGINA OCCURRED. THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 18MM IN LENGTH, DE NOVO, 80% STENOSED TARGET LESION 1 WAS LOCATED IN THE 3.5MM IN DIAMETER MID RIGHT CORONARY ARTERY (RCA). A 3.50MM X 24MM PROMUS ELEMENT PLUS STENT WAS ADVANCED AND DEPLOYED IN THE TARGET LESION WITH 10% RESIDUAL STENOSIS. THE 14MM IN LENGTH, DE NOVO, 80% STENOSED TARGET LESION 2 WAS LOCATED IN THE 2.75MM IN DIAMETER MID LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 20MM PROMUS ELEMENT PLUS STENT WAS ADVANCED AND PLACED IN THE TARGET LESION WITH 0% RESIDUAL STENOSIS. ONE-DAY POST-PROCEDURE, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2013, THE SUBJECT PRESENTED WITH CHEST PAIN AND WAS HOSPITALIZED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333907 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911420270 0014960489

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization