BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1142743 · Received August 27, 2008

    Report

    Report Number
    2024168-2008-00722
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 28, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P090015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT. DISSECTION, AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU) IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING AND IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. DISSECTION CAN BE INFLUENCED BY SEVERAL FACTORS, INCLUDING BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. THE IFU ALSO STATES, "IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENT AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION (CABG, FURTHER DILATATION, PLACEMENT OF ADDITIONAL STENTS, OR OTHER)." A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: DISSECTION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED VIA A SPIRIT TRIAL THAT AFTER IMPLANT OF A 2.5 X 28 MM XIENCE V STENT IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD), A DISSECTION WAS NOTED DISTAL TO THE IMPLANT. ADDITIONAL STENTS WERE IMPLANTED TO TREAT THE DISSECTION AND THE PATIENT WAS HOSPITALIZED. 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 7100341

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R