BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3831016 · Received May 23, 2014

    Report

    Report Number
    2024168-2014-03326
    Event Type
    Death
    Date Received
    May 23, 2014
    Date of Event
    August 1, 2012
    Report Date
    April 23, 2014
    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 DEATH ESTIMATED AS (B)(6) 2012. DATE OF OCCURRENCE ESTIMATED AS (B)(6) 2012. DATE OF IMPLANT ESTIMATED AS (B)(6) 2008 THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS A KNOWN PATIENT EFFECT OF 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE OF A NON-ABBOTT (TWENTE) CLINICAL 2 YEAR STUDY THAT PATIENTS WERE RANDOMIZED TO EITHER A XIENCE V STENT OR A NON-ABBOTT 2ND GENERATION STENT. SOME OF THE PATIENTS HAD THE STENT IMPLANTED COVERING THE AORTA-OSTIAL (AO) REGION OF THE RIGHT CORONARY ARTERY (RCA) AND SOME OF THE PATIENTS HAD THE STENT IMPLANTED NOT COVERING THE AO REGION OF THE RCA. AVAILABLE PATIENT INFORMATION IS DOCUMENTED. THIS IS BEING FILED TO REPORT THE POTENTIALLY RELATED CARDIAC DEATHS FROM THE XIENCE V STENT GROUP. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED 'CLINICAL OUTCOME OF PATIENTS WITH IMPLANTATION OF SECOND-GENERATION DRUG-ELUTING STENTS IN THE RIGHT CORONARY OSTIUM: INSIGHTS FROM 2-YEAR FOLLOW-UP OF THE TWENTE TRIAL.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307599 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death