BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1894980 · Received November 5, 2010

    Report

    Report Number
    2024168-2010-02369
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 13, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) PT SELECTION. THE REPORTED MYOCARDIAL INFARCTION, THROMBOSIS, RESTENOSIS, AND HOSPITALIZATION ARE KNOWN ADVERSE EVENTS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN. IT WAS REPORTED THAT THE 3.50 X 28 MM XIENCE V STENT WAS IMPLANTED TO TREAT RESTENOSIS OF A PREVIOUSLY IMPLANTED STENT, IT SHOULD BE NOTED THAT THE XIENCE V IFU STATES: "THE SAFETY AND EFFECTIVENESS OF THE XIENCE V STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH IN-STENT RESTENOSIS." IT CANNOT BE DETERMINED WHETHER THE IFU DEVIATION CONTRIBUTED TO THE REPORTED PT EFFECTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO VISIONS STENTS WERE IMPLANTED IN THE RIGHT CORONARY ARTERY (RCA) LESION ON (B)(6) 2009. ON (B)(6) 2010, A 3.5 X 28 MM AND A 3.5 X 18 MM XIENCE V STENTS WERE IMPLANTED IN THE RCA LESION BECAUSE OF THE RESTENOSIS OF THE VISION STENT. THE STENOSIS IMPROVED FROM 90% TO 0%. THE VESSEL DIAMETER AND LENGTH WHICH XIENCE V STENTS WERE IMPLANTED: 3.5MM AND 40MM. ON (B)(6) 2010, THE PT WAS REHOSPITALIZED COMPLAINING OF CHEST PAIN .STENOSIS WITH THROMBOSIS WAS CONFIRMED ON ANGIOGRAM IN THE 3.5 X 28 MM XIENCE V STENT, ST EVALUATIONS WERE CONFIRMED AS MYOCARDIAL INFARCTION. A 3.0 X 12 MM XIENCE V WAS IMPLANTED FOR TREATMENT OF THE RESTENOSIS AND THROMBOSIS. THE PHYSICIAN COMMENTED THAT THROMBOSIS OCCURRED DUE TO THE PLAQUE RUPTURE AT THE RESTENOSIS OF 3.5 X 28 MM XIENCE V, BECAUSE IT WAS DIFFICULT TO CROSS THE STENOSIS PART WITH A GUIDE WIRE. NO ADDITIONAL INFO WAS 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 9121861

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R| S