BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1980213 · Received February 7, 2011

    Report

    Report Number
    2024168-2011-00722
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    March 29, 2010
    Report Date
    January 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. STENT: XIENCE V 2.5 X 28, (1009539-28, LOT#8082762), XIENCE V 4.0 X 18 (1009543-18, LOT#8061261). THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA, ISCHEMIA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THEIR RELATIONSHIP, IF ANY, TO THE DEVICES CANNOT BE DETERMINED; THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT APPROXIMATELY FIFTEEN MONTHS POST MULTIPLE XIENCE V STENTING IN THE FIRST POSTEROLATERAL ARTERY, PROXIMAL CIRCUMFLEX (PCX) ARTERY AND THE LEFT MAIN CORONARY ARTERY, THE PATIENT EXPERIENCED DIAPHORESIS, DYSPNEA ON EXERTION AND MILD CHEST TIGHTNESS AND WAS FOUND TO HAVE A POSITIVE FUNCTIONAL STRESS TEST DEMONSTRATING MYOCARDIAL ISCHEMIA. THE PATIENT WAS TREATED WITH MEDICATIONS AND UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION IN THE PCX INDEX TARGET LESION FOR IN-STENT RESTENOSIS ON (B)(6) 2010. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2010 AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, 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 8042461

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R