BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1151438 · Received September 5, 2008

    Report

    Report Number
    2024168-2008-00775
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    July 7, 2008
    Report Date
    August 8, 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 DETERMINED THAT DISSECTION, AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU), IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. DISSECTION IS NOT NECESSARILY AN INDICATION OF A PROD QUAL ISSUE AND IN THIS CASE, THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION AT THE TIME OF IMPLANT. DISSECTION CAN BE INFLUENCED BY SEVERAL FACTORS, INCLUDING BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. IT SHOULD BE NOTED THAT THE IFU ALSO STATES, "IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENT MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADD'L INTERVENTION."

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY. REPORTING RATIONALE: DISSECTION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED THAT A DISSECTION OCCURRED WHILE IMPLANTING A XIENCE V 2.5 X 23 IN THE MID TO DISTAL RCA, AND WAS OBSERVED AT THE DISTAL PART OF THE STENT. ANOTHER XIENCE V 2.25 X 28 WAS USED TO COVER THE DISSECTION. 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 8010861

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention DILATATION CATHETER: 2.0 X 12| GUIDE WIRE: ALLSTAR