BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1211512 · Received October 22, 2008

    Report

    Report Number
    2024168-2008-01004
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 22, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - PERMANENT IMPAIRMENT. REPORTING RATIONALE: DEVICE REMAINS IN PATIENT. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THERE WAS DIFFICULTY INSERTING THE STENT INTO THE ROTATING HEMOSTATIC VALVE, AND THE STENT DISLODGED INTO THE LEFT CORONARY ARTERY. THE STENT REMAINS IN THE PATIENT. ANOTHER STENT WAS USED TO END THE PROCEDURE. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability GUIDE WIRE: BMW| RHV: PPAK 20/30 W/COPILOT