BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4108237 · Received September 22, 2014

    Report

    Report Number
    2024168-2014-06101
    Event Type
    Injury
    Date Received
    September 22, 2014
    Date of Event
    March 17, 2014
    Report Date
    July 3, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE ESTIMATED AS (B)(6) 2014, EXACT DATE WAS NOT REPORTED. THE PROMUS DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. LITERATURE ATTACHMENT: JOSHUA P. LOH, MBBS, REBECCA TORGUSON, MPH, LAKSHMANA K. PENDYALA, MD, ALFAZIR OMAR, MBCHB, PHD, FANG CHEN, PHD, LOWELL F. SATLER, MD, AUGUSTO D. PICHARD, MD, AND RON WAKSMAN, MD. (AM J CARDIOL 2014; 113:1968-1976): IMPACT OF EARLY VERSUS LATE CLOPIDOGREL DISCONTINUATION ON STENT THROMBOSIS FOLLOWING PERCUTANEOUS CORONARY INTERVENTION WITH FIRST- AND SECOND-GENERATION DRUG-ELUTING STENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE XIENCE V AND PROMUS STENTS THAT MAY BE RELATED TO STENT THROMBOSIS AND MYOCARDIAL INFARCTION. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED IMPACT OF EARLY VERSUS LATE CLOPIDOGREL DISCONTINUATION ON STENT THROMBOSIS FOLLOWING PERCUTANEOUS CORONARY INTERVENTION WITH FIRST- AND SECOND-GENERATION DRUG-ELUTING STENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586806 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability