BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1972107 · Received January 27, 2011

    Report

    Report Number
    2024168-2011-00500
    Event Type
    Injury
    Date Received
    January 27, 2011
    Date of Event
    March 10, 2010
    Report Date
    January 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED RESTENOSIS, ANGINA AND ISCHEMIA ARE LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. 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 OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY THIRTY EIGHT MONTHS POST STENTING PROCEDURE IN THE FIRST OBTUSE MARGINAL WITH ONE 2.5X28 XIENCE V STENT, THE PATIENT EXPERIENCED ANGINA WITH DYSPNEA AND WAS FOUND TO HAVE A POSITIVE FUNCTIONAL STRESS TEST DEMONSTRATING MYOCARDIAL ISCHEMIA. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION WITH A NON-ABBOTT DRUG ELUTING STENT ON (B)(6) 2010. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2010. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 60818P2

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R