BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION SV RX

    MDR report key: 3231301 · Received July 11, 2013

    Report

    Report Number
    MW5030900
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    January 28, 2013
    Report Date
    July 11, 2013
    Manufacturer
    ABBOTT VASCULAR DEVICES
    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) 2013 ADMITTED THROUGH ER WITH NON STEMI. TAKEN TO CCL (B)(6) 2013 AT 0941. FILMS REVEAL A 95% HAZY LESION IN MID LAD. PREDILATED WITH 2.0X12 MINI TREK OTW, AND 2.25X12 XIENCE XPEDITION RX DEPLOYED, TIMI III FLOW, 0% RESIDUAL STENOSIS. MEDICATIONS GIVEN INCLUDED ASA, HEPARIN, ANGIOMAX, AND PRASUGREL. TO CSSU AT 1027. AT 1200 ACUTE ONSET OF RECURRENT CHEST PAIN WITH ST ELEVATION. ACUTE STENT THROMBOSIS FOLLOWING STENT PLACEMENT. WIRE ADVANCED ACROSS LESION WITH SPONTANEOUS RECANALIZATION. A 2.0X12 MINI TREK OTW TO PERFORM OVERLAPPING INFLATIONS INSIDE OF STENT. DUE TO VERY SMALL CALIBER OF VESSEL, A 2.25X28 XIENCE NANO RX PLACED THROUGH PREVIOUS STENT OVERLAPPING AT PROXIMAL AND DISTAL ENDS. PT WAS ADMINISTERED A MORE AGGRESSIVE ANTI-PLATELET THERAPY OVERNIGHT INCLUDING INTEGRILIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321426 XIENCE XPEDITION SV RX XIENCE XPEDITION SV RX MAF ABBOTT VASCULAR DEVICES 2092441

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention