BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX

    MDR report key: 1983667 · Received February 4, 2011

    Report

    Report Number
    MW5019328
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    September 22, 2010
    Report Date
    February 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT PRESENTED TO AN OUTLYING FACILITY WITH AN MI, A VERIFLEX 3.0X20 STENT WAS PLACED IN THE PROXIMAL CIRCUMFLEX. ON (B)(6) 2010, PT PRESENTED TO SAME OUTLYING FACILITY WITH A STEMI, AND SUBACUTE THROMBOSIS OF THAT PREVIOUSLY PLACED STENT. TREATED WITH ANGIOPLASTY AND THROMBECTOMY. ON (B)(6) 2010, PT PRESENTS TO OUR FACILITY WITH A NON-STEMI. HE HAD REPORTEDLY STOPPED HIS EFFIENT 1-2 WEEKS PRIOR TO THIS ADMISSION. FILMS REVEAL A DOMINANT CIRCUMFLEX TOTALLY OCCLUDED PROXIMALLY AT SITE OF PREVIOUSLY PLACED STENT. THROMBECTOMY PERFORMED REMOVING LARGE AMOUNT OF CLOT. A 3.0X15 NC QUANTUM APEX INFLATED FOUR TIMES. FLOW MARKEDLY IMPROVED, BUT WITH 50% RESIDUAL STENOSIS. FILMS DISCUSSED WITH SURGEON. BYPASS FELT TO BE BEST OPTION CONSIDERING 3 MI'S SINCE (B)(6) 2010, AND NON-COMPLIANCE WITH MEDICATIONS TWICE RESULTING IN SUBACUTE THROMBOSIS. PT TO CAB LATER THAT SAME DAY. REST OF ADMISSION UNEVENTFUL, DISCHARGED (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX MAF BOSTON SCIENTIFIC 13197871

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Disability