BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3203038 · Received July 2, 2013

    Report

    Report Number
    2024168-2013-04152
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS NOT PERFORMED AS THE LOT NUMBER WAS NOT REPORTED AND THE DEVICE WAS NOT RETURNED. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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).. ESTIMATED DATE OF EVENT. ESTIMATED DATE OF IMPLANT. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANTATION OF AN UNSPECIFIED RX XIENCE STENT IN AN UNSPECIFIED VESSEL, THE PATIENT HAS DEVELOPED UNSPECIFIED PSYCHOLOGICAL EFFECTS. REPORTEDLY, THE PHYSICIAN HAS RESEARCHED THE EVEROLIMUS DRUG AND FOUND THAT IT CAN CAUSE PSYCHOLOGICAL EFFECTS, AND IS REQUESTING INFORMATION REGARDING POTENTIAL PSYCHOLOGICAL EFFECTS OF EVEROLIMUS ON PATIENT, IF ANY INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302012 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other