BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3111209 · Received May 14, 2013

    Report

    Report Number
    2134265-2013-03571
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 3, 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

    (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - DEVICE NOT RETURNED THEREFORE ANALYSIS OF COMPLAINT DEVICE COULD NOT BE PERFORMED. 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 MFR ID # 2134265-2013-03568. IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. THE 3.0X8MM, 90% STENOSED TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE DISTAL LESION WAS PRE-DILATED AND THE 3.0X8MM PROMUS ELEMENT STENT WAS DEPLOYED, RESULTING IN 0% RESIDUAL STENOSIS. THE 3.0X24MM, 70% STENOSED PROXIMAL RIGHT CORONARY ARTERY (RCA) WAS THEN PRE-DILATED, DURING DILATION A SMALL INTIMAL DISSECTION WAS NOTED WHICH DID NOT SPREAD. THE 3.0X28MM PROMUS ELEMENT PLUS STENT WAS DEPLOYED, RESULTING IN 0% RESIDUAL STENOSIS. THE FOLLOWING DAY, PATIENT EXPERIENCED ELEVATED CARDIAC ENZYMES MEETING THE CLINICAL DEFINITION OF A MYOCARDIAL INFARCTION. NO ADDITIONAL INTERVENTION WAS REQUIRED. PATIENT WAS DISCHARGED THE SAME DAY ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211914 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911408300 15494269

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other