BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2791464 · Received October 15, 2012

    Report

    Report Number
    2134265-2012-06097
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    March 15, 2011
    Report Date
    September 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). 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 POST A STENTING TREATMENT PROCEDURE, A MYOCARDIAL INFARCTION (MI) OCCURRED. IN (B)(6) 2011, THE PATIENT PRESENTED WITH SILENT ISCHEMIA, AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 20MM X 3.48MM, 70% STENOSED TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.00 MM X 20 MM PROMUS ELEMENT STENT. FOLLOWING POST DILATATION RESIDUAL STENOSIS WAS 0%. TH PROCEDURE WAS CONSIDERED AS HAVING "GOOD ANGIOGRAPHIC RESULTS." THE NEXT DAY, PRIOR TO DISCHARGE, ELEVATED TROPONIN VALUES WERE OBSERVED IN THE POST PROCEDURE LAB RESULTS AND AN MI WAS REPORTED (PEAK TROPONIN= 0.51 NG/ML; ULN= 0.1 NG/ML). AN ELECTROCARDIOGRAM WAS PERFORMED (MI TYPE - NON Q-WAVE). THERE WAS NO REPORT OF STENT THROMBOSIS OR ABRUPT CLOSURE AND THE PATIENT DID NOT EXPERIENCE ANY ISCHEMIC SYMPTOMS. THE PATIENT WAS DISCHARGED THE SAME DAY ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320300 14113960

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention