BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1133289 · Received August 22, 2008

    Report

    Report Number
    2024168-2008-00706
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    March 20, 2008
    Report Date
    July 29, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION: THROMBOSIS IS NOTED IN THE PROD INSTRUCTIONS FOR USE (IFU) AS A KNOWN DEVICE EVENT ASSOCIATED WITH CORONARY STENTING. FACTORS THAT CAN CONTRIBUTE TO PLAQUE SHIFT INCLUDE BUT ARE NOT LIMITED TO, LESION CHARACTERISTICS, DEVICE SIZE SELECTION, AND PROCEDURAL TECHNIQUE. THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION DURING THE IMPLANT OF THE RX XIENCE STENT. IN THIS CASE, THE THROMBOSIS AND PLAQUE SHIFT WERE SUCCESSFULLY TREATED WITH THE PLACEMENT OF ANOTHER STENT. THERE IS NO INDICATION OF A PROD QUAL ISSUE WITH THE RX XIENCE STENT. HOWEVER, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED PT EFFECTS, AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/ MEDICAL INTERVENTION. REPORTING RATIONALE: THROMBOSIS REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. DEVICE ISSUE: NONE. IT WAS REPORTED VIA A TRIAL THAT AFTER IMPLANTING THE RX XIENCE V STENT, IT WAS NOTED THAT THERE WAS PLAQUE SHIFT AND STENT THROMBOSIS. ANOTHER STENT WAS IMPLANTED OVERLAPPING THE FIRST STENT, AND THE ISSUES WERE RESOLVED THE SAME DAY. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention