BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3180536 · Received June 20, 2013

    Report

    Report Number
    2134265-2013-04292
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    April 12, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). 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).

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM, RELEVANT TESTS/LAB DATA, AND PATIENT CODE UPDATED. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT BASELINE CORE LAB ANGIOGRAPHY RESULT REVEALED 0% SIDE BRANCH STENOSIS AT DISTAL LEFT CIRCUMFLEX. POST PROCEDURE ANGIOGRAPHY REVEALED 70% 'BRANCH PERCENT STENOSIS' IN DISTAL LEFT CIRCUMFLEX. THE FOLLOWING DAY MYOCARDIAL INFARCTION OCCURRED. NO ACTION WAS TAKEN IN RESPONSE TO THE EVENT.

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT DURING POST PERCUTANEOUS CORONARY INTERVENTION, TROPONIN ELEVATION OCCURRED. ON (B)(6) 2013, IDENTIFIED THE SUBJECT¿S QUALIFYING CONDITIONS AS STABLE ANGINA AND THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION. THE SUBJECT WAS RANDOMIZED INTO THE (B)(6) STUDY AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. TARGET LESION #1 WAS LOCATED IN THE DISTAL LEFT CIRCUMFLEX ARTERY WITH 90% STENOSIS, A LENGTH OF 24 MM, WITH A REFERENCE VESSEL DIAMETER OF 3 MM. TARGET LESION # 1 WAS TREATED WITH PRE DILATATION AND PLACEMENT OF A 3.00 X 28 MM STUDY STENT WITH 0% RESIDUAL STENOSIS. ON THE NEXT DAY, SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. THE SAME DAY, TROPONIN ELEVATION OCCURRED. CARDIAC ENZYMES WERE NOTED TO BE ELEVATED CONSISTENT WITH PROTOCOL DEFINITION OF MI ( PEAK TROPONIN: 0.48 NG/ML ULN: 0.04).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280217 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911428300 15661570

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention