BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2771003 · Received October 3, 2012

    Report

    Report Number
    2024168-2012-06253
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 11, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF IMPLANT ESTIMATED. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECT OF THROMBOSIS IS LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. DATE OF EVENT ESTIMATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A REPEAT PROCEDURE FOR A PREVIOUSLY IMPLANTED XIENCE PRIME STENT. IT WAS NOTED THAT THERE WAS A SIZE DISCREPANCY OF THE VESSEL IN THE MID AREA OF THE STENT, AND THROMBUS WAS OBSERVED BETWEEN THE STENT AND THE INTIMA. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AND THE DIAMETER OF THE VESSEL WAS APPROXIMATELY 3 MM. THE MID PORTION OF THE STENT WAS TREATED WITH DILATATION. ADDITIONAL IVUS WAS PERFORMED AND A GOOD RESULT WAS CONFIRMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R