BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NG PROMUS

    MDR report key: 3062029 · Received April 16, 2013

    Report

    Report Number
    2134265-2013-02308
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).DEVICE IS COMBINATION PRODUCT.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)(6) CLINICAL STUDY. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, VESSEL DISSECTION OCCURRED. IN (B)(6)-2013, CLINICAL STATUS ASSESSMENT IDENTIFIED THE PATIENTS' QUALIFYING CONDITION AS MYOCARDIAL INFARCTION (MI). AN ELEVATED BIOMARKERS INDICATED ISCHEMIA PRIOR TO PROCEDURE. THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 1ST TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50 X 20 MM PROMUS ELEMENT PLUS PLUS STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. THE 2ND TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 28 MM PROMUS ELEMENT PLUS PLUS STENT, RESULTING IN A GRADE A DISSECTION PROXIMAL TO THE TARGET LESION AND REQUIRING INTERVENTION. SUBSEQUENTLY, A 3.50 X 12 MM PROMUS ELEMENT PLUS PLUS STENT WAS IMPLANTED TO TREAT THE DISSECTION. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. THE EVENT WAS CONSIDERED RESOLVED THE SAME DAY AND THE PATIENT WAS DISCHARGED 2 DAYS AFTER THE EVENT ON ASPIRIN AND TICAGRELOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161988 NG PROMUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493925028250

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention