BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1741415 · Received June 28, 2010

    Report

    Report Number
    2024168-2010-01276
    Event Type
    Injury
    Date Received
    June 28, 2010
    Date of Event
    June 2, 2010
    Report Date
    June 3, 2010
    Manufacturer
    ABBOTT VASCULAR CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). THE XIENCE V RX 3.5 X 18 MM (PART # 1009542-18, LOT # 9122142) IS BEING REPORTED UNDER THE SAME MEDWATCH MFR NUMBER. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE ISSUE: INCOMPLETE WALL APPOSITION. TIME OF DEVICE ISSUE: DURING THE INITIAL PROCEDURE. ADVERSE EVENT: THROMBOSIS REQUIRING INTERVENTION. TIME OF ADVERSE EVENT: AFTER THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2010, A 3.5 X 18 XIENCE V STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND A 3.0 X 18 XIENCE V STENT WAS IMPLANTED IN THE DISTAL LEFT CIRCUMFLEX (LCX) ARTERY. IVUS WAS PERFORMED AFTER DEPLOYMENT AND THE STENTS WERE CONFIRMED TO BE PROPERLY DILATED. ON (B)(6) 2010, THE PT EXPERIENCED CHEST PAIN. CORONARY ANGIOGRAPHY FOUND THE XIENCE V STENTS WERE NOT FULLY APPOSED TO THE VESSEL WALL DURING INITIAL DEPLOYMENT, AND IN-STENT THROMBOSIS FORMED WHICH REQUIRED ASPIRATION AND DILATATION OF THE STENTS WITH AN UNSPECIFIED BALLOON CATHETER. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR CLONMEL NA 0030141

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention XIENCE V RX 3.5 X 18 MM (PART # 1009542-18,| LOT #9122142)