BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1784644 · Received July 30, 2010

    Report

    Report Number
    2024168-2010-01535
    Event Type
    Injury
    Date Received
    July 30, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 7, 2010
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE STENT: 3.0 X 28 MM XIENCE V (PART 1009529-28, LOT 0031041), IS BEING FILED UNDER A SEPARATE MFR.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: DISSECTION. ONSET OF ADVERSE EVENT: DURING THE PROCEDURE. IT WAS REPORTED THAT RESISTANCE WAS MET WHEN THE 3.5 X 18 XIENCE V STENT WAS ADVANCED IN A PREDILATED, TORTUOUS AND CALCIFIED, BUT UNSPECIFIED TARGET LESION. AFTER THE XIENCE V STENT WAS DEPLOYED, A DISSECTION WAS IDENTIFIED. A 3.0 X 28 XIENCE V STENT WAS IMPLANTED TO SEAL THIS DISSECTION, BUT ALSO RESULTED IN A SECOND DISSECTION. TWO NON-ABBOTT BARE METAL STENTS WERE THEN IMPLANTED TO TREAT THESE DISSECTIONS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    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 0031041

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention STENT: 3.0 X 28 MM XIENCE V| (PART 1009529-28, LOT 0031041)