BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1140232 · Received August 29, 2008

    Report

    Report Number
    2024168-2008-00738
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 7, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. DISSECTION, AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU), IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. DISSECTION CAN BE INFLUENCED BY SEVERAL FACTORS, INCLUDING LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE AND DEVICE SIZE SELECTION. DISSECTION IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE AND IN THIS CASE THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION. A CONCLUSIVE CAUSE FOR THE DISSECTION IN THIS CASE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: DISSECTION REQUIRING ADDITIONAL STENTING. DEVICE ISSUE: NONE. IT WAS REPORTED THAT A DISSECTION OCCURRED WHILE IMPLANTING THE 3.0 X 28 MM XIENCE V STENT. A NEW XIENCE V STENT WAS USED TO COVER THE DISSECTION. 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 8022041

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention GUIDE WIRE: BMW