BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3061304 · Received April 16, 2013

    Report

    Report Number
    2024168-2013-02316
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    October 23, 2012
    Report Date
    March 13, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF OCCLUSION, RESTENOSIS, AND MYOCARDIAL INFARCTION AS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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. THE PROMUS DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. THE ADDITIONAL ADVERSE PATIENT EFFECT OF DEATH REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW. IT WAS REPORTED THAT A SINGLE-CENTER NON-RANDOMIZED STUDY IDENTIFIED A TOTAL OF 802 PATIENTS WITH CHRONIC TOTAL OCCLUSION (CTO), OF WHICH 273 RECEIVED EITHER UNSPECIFIED XIENCE V STENTS OR UNSPECIFIED PROMUS STENTS BETWEEN 2003 TO 2010. CLINICAL OUTCOMES WERE AS FOLLOWS: THIRTY (30) PATIENTS WITH IN-STENT RESTENOSIS/REOCCLUSION. THIRTY ONE (31) PATIENTS WITH TARGET CTO VESSEL REVASCULARIZATION. ONE (1) PATIENT WITH MYOCARDIAL INFARCTION. THREE (3) PATIENTS WITH CARDIOVASCULAR DEATH. THIRTY FOUR (34) PATIENTS WITH MAJOR ADVERSE CARDIOVASCULAR EVENT (INCLUDING TVR, NONFATAL MI, CARDIOVASCULAR DEATH). NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163851 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S