BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3190684 · Received June 26, 2013

    Report

    Report Number
    2024168-2013-03992
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    November 1, 2012
    Report Date
    June 19, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF STENOSIS/RESTENOSIS IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. 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

    IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT A STENTING PROCEDURE WITH PLACEMENT OF A 3.0 X 23 MM XIENCE V STENT IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. APPROXIMATELY 16 MONTHS POST STENTING PROCEDURE, THE PATIENT WAS RE-HOSPITALIZED AND RESTENOSIS WAS NOTED. PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED AND THE PATIENT CONDITION RESOLVED ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290403 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0120841

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R OTHER: ASPIRIN, CLOPIDOGREL