BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3926445 · Received July 10, 2014

    Report

    Report Number
    2024168-2014-04430
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 27, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE OTHER XIENCE PRIME REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. STENOSIS AND ISCHEMIA ARE LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE (IFU) 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, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, A 3.5X33MM XIENCE PRIME STENT WAS SUCCESSFULLY IMPLANTED IN THE MID RIGHT CORONARY ARTERY. ON (B)(6) 2013, A 3.0X23MM XIENCE PRIME STENT WAS SUCCESSFULLY IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (MLAD) CORONARY ARTERY. ON (B)(6) 2014, THE PATIENT WAS HOSPITALIZED DUE TO SILENT ISCHEMIA. ON (B)(6) 2014, THE PATIENT WAS FOUND TO HAVE 90% IN-STENT RESTENOSIS IN BOTH STENTED LESIONS. PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED IN THE MID LEFT ANTERIOR DESCENDING AND THE MID RIGHT CORONARY ARTERIES, RESOLVING THE EVENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404653 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2091341

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R STENT: XIENCE PRIME 3.5X33MM