BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NG PROMUS

    MDR report key: 2962360 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00731
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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 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) TRIAL. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), A DEPLOYMENT ISSUE OCCURRED. THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA IIB AND OBJECTIVE EVIDENCE OF ISCHEMIA AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND WAS 24MM LONG WITH A REFERENCE DIAMETER OF 3.5MM AND WITH 80% STENOSIS. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF 3.0X38 MM AND 4.0X12 MM NG PROMUS STENTS. DURING THE PROCEDURE, IVUS WAS PERFORMED AND IT WAS NOTED THAT THE STENTS WERE "GENERALLY WELL OPPOSED" THOUGH UNDER-EXPANSION OF THE 3.0X38 MM STENT WAS SUSPECTED. THIS WAS TREATED WITH BALLOON DILATATION. FINAL ANGIOGRAPHIC ASSESSMENT WAS "EXCELLENT". THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65886 NG PROMUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493925038300 15490109

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention