BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3842863 · Received June 2, 2014

    Report

    Report Number
    2134265-2014-03030
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 3, 2014
    Report Date
    May 5, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. 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)(6) CLINICAL STUDY. IT WAS REPORTED THAT MYOCARDIAL INFARCTION (MI) AND RESTENOSIS OCCURRED. IN (B)(6) 2013, CLINICAL STATUS ASSESSMENT IDENTIFIED THE PATIENT'S QUALIFYING CONDITION WAS SILENT ISCHEMIA WITH UNSTABLE ANGINA. THE PATIENT WAS REFERRED FOR URGENT CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH 99% STENOSIS, A LENGTH OF 20 MM, AND A REFERENCE VESSEL DIAMETER OF 3.00 MM. THE LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 3.00 X 20 MM STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2013, THE PATIENT PRESENTED WITH CONSTRICTING FEELING IN THE THROAT AND PATIENT DEVELOPED MI. NO CLEAR ISCHAEMIA WAS NOTED ON ECG, HOWEVER ELEVATED TROPONIN WAS NOTED. SUBSEQUENTLY, PATIENT WAS ADMITTED FOR CORONARY ANGIOGRAPHY. CARDIAC ENZYMES WERE NOTED TO BE ELEVATED (PEAK TROPONIN T: 0.045 NG/ML, ULN: 0.03 NG/ML) CONSISTENT WITH SPONTANEOUS MI. THE 90% STENOSIS IN THE DISTAL RCA WAS TREATED WITH AN UNSPECIFIED DRUG-ELUTING STENT, RESULTING TO TIMI 3 FLOW. TWO DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320880 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911420300 15615513

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention