BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3092711 · Received May 3, 2013

    Report

    Report Number
    2024168-2013-02778
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 26, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA AND THROMBOSIS, ARE LISTED IN THE JAPAN XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT 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, DESIGN, OR LABELING. THE ADDITIONAL XIENCE PRIME REFERENCED IN IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO XIENCE PRIME STENTS WERE IMPLANTED ON (B)(6) 2012 TO TREAT 99% IN-STENT RE-STENOSIS OF A NON-ABBOTT STENT. ON (B)(6) 2013, THE PATIENT PRESENTED TO THE HOSPITAL WITH CHEST PAIN. ANGIOGRAPHY WAS PERFORMED AND IT WAS OBSERVED THAT THERE WAS 99% HAZINESS WAS OBSERVED WHERE THE TWO XIENCE PRIME STENTS WERE OVERLAPPED. IT WAS NOTED THAT LATE STENT THROMBOSIS WAS SUSPECTED. A THROMBECTOMY DEVICE WAS ADVANCED, BUT COULD NOT REACH TO THE RESTENOSIS; THEREFORE, A CUTTING BALLOON WAS USED. THROMBECTOMY WAS THEN PERFORMED SUCCESSFULLY. THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193854 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2040241

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R STENT: 2.5 X 38 MM XIENCE PRIME LL