BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2944427 · Received February 5, 2013

    Report

    Report Number
    2024168-2013-00656
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    July 12, 2012
    Report Date
    January 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. DATE OF EVENT ESTIMATED AS DATE OF PUBLICATION. DATE OF IMPLANT ESTIMATED. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, OCCLUSION, THROMBOSIS, AND STENOSIS/RESTENOSIS ARE LISTED IN THE XIENCE V 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.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON REVIEW OF AN ARTICLE. IT WAS REPORTED THAT FROM (B)(6) 2008 THROUGH (B)(6) 2010, (B)(4) PATIENTS WITH AN INDICATION FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH DRUG ELUTING STENT (DES) IMPLANTATION WERE RANDOMIZED FOR TREATMENT WITH A NON-ABBOTT STENT OR XIENCE V STENT. THE STUDY POPULATION WAS GROUPED INTO PATIENTS WITH A KNOWN HISTORY OF DIABETES MELLITUS VERSUS PATIENTS WITHOUT A HISTORY OF DIABETES. CLINICAL OUTCOMES WERE AS FOLLOWS: (B)(4) SIDE BRANCH OCCLUSION, (B)(4) DISTAL EMBOLIZATION, (B)(4) PERI-PROCEDURAL MYOCARDIAL INFARCTION, (B)(4) STENT THROMBOSIS, (B)(4) TARGET VESSEL REVASCULARIZATION, (B)(4) TARGET VESSEL MYOCARDIAL INFARCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48546 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