BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1200661 · Received October 17, 2008

    Report

    Report Number
    2024168-2008-00970
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 19, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION- PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS. IN THIS CASE, THE FAILURE TO CROSS APPEARS TO BE RELATED TO THE INTERACTION OF THE SDS WITH THE PREVIOUSLY IMPLANTED STENT. POTENTIAL CAUSES FOR STENT DISLODGEMENT MAY INCLUDE INTERACTION OF THE STENT WITH THE LESION, ACCESSORY DEVICES AND/OR PREVIOUSLY IMPLANTED STENTS. IT IS LIKELY THAT THE ATTEMPT TO CROSS A PREVIOUSLY IMPLANTED STENT AND THE INTERACTION BETWEEN THAT STENT AND THE SDS CONTRIBUTED TO THE REPORTED STENT DISLODGEMENT.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY-MEDICAL INTERVENTION. REPORTING RATIONALE: REMOVAL OF DISLODGED STENT FROM PT. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE 3.0 X 23 MM XIENCE V WAS UNABLE TO CROSS THROUGH A PREVIOUSLY STENTED VESSEL. DURING THE ATTEMPT THE STENT DISLODGED. THE DISLODGED STENT WAS SUCCESSFULLY RETRIEVED. THERE WERE NO PT EFFECTS REPORTED. NO ADD'L EVENT OR PT INFO 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 8051261

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention