BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V OTW

    MDR report key: 1951127 · Received December 30, 2010

    Report

    Report Number
    MW5018854
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    April 1, 2010
    Report Date
    December 30, 2010
    Manufacturer
    ABBOTT LABS-CRITICAL CARE
    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) 2009 PT WITH 99% OSTIAL LAD LESION STENTED WITH 2.75X13 XIENCE V, AND A 2.75X8 XIENCE V. DISCHARGED ON ASA AND PLAVIX. ON (B)(6) 2010, PT RETURNS FOR CATH POSSIBLE PCI DUE TO RECURRENT ISCHEMIC SYMPTOMS AND ABNORMAL THALLIUM SCAN. OSTIAL LAD TOTALLY OCCLUDED BY IN-STENT THROMBOSIS. PRE-DILATED WITH A 2.5X15 QUANTUM MAVERICK. A 2.75X23 XIENCE V DEPLOYED WITH RESTORATION OF TIMI III FLOW. SUSPECT THAT THE PT MAY BE A PLAVIX NON-RESPONDER RESULTING IN IN-STENT THROMBOSIS. PT SWITCHED TO PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V OTW NIQ ABBOTT LABS-CRITICAL CARE 9013061
    2 XIENCE V RX NIQ ABBOTT LABS-CRITICAL CARE 8111861

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Disability