BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE MONORAIL

    MDR report key: 1951129 · Received December 30, 2010

    Report

    Report Number
    MW5018857
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    September 22, 2010
    Report Date
    December 30, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    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 STEMI, PROXIMAL RCA 100% OCCLUSION WITH THROMBUS. THROMBECTOMY PERFORMED, 2.75X38 TAXUS LIBERTE LONG MONORAIL TIMES TWO, 2.75X20 TAXUS LIBERTE MONORAIL DEPLOYED FROM MID TO PROXIMAL RCA. DISCHARGED ON ASA AND PRASUGREL. ON (B)(6) 2010 TRANSFERRED FROM OUTLYING FACILITY WITH STEMI. EMERGENTLY TO (B)(4). FILMS REVEAL 80% OCCLUSION WITH THROMBUS IN PREVIOUSLY PLACED PROXIMAL RCA STENT. A 3.0X10 FLEXTOME INFLATED, AND A 3.0X38 TAXUS LIBERTE LONG OTW PLACED FROM PROXIMAL TO MID RCA. IT WAS DETERMINED THAT PT HAD BEEN NON-COMPLIANT WITH MEDS FOR 2 MONTHS PRIOR TO PRESENTATION. DISCHARGED ON ASA AND PRASUGREL WITH EXTENSIVE DISCUSSION OF IMPORTANCE OF MEDICAL COMPLIANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE MONORAIL NIQ BOSTON SCIENTIFIC 13154433

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability