BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1991467 · Received February 15, 2011

    Report

    Report Number
    2024168-2011-00921
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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. 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 FOURTEEN MONTHS POST STENTING WITH ONE 2.5 X 12 XIENCE V STENT IN THE PROXIMAL FIRST DIAGONAL BRANCH, THE PATIENT EXPERIENCED DYSPNEA AND CHEST PAIN. ON (B)(6) 2011, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION FOR 80% IN-STENT RESTENOSIS IN THE INDEX TARGET LESION. THE PATIENT'S CONDITION RESOLVED ON 01/12/2011 AND THE PATIENT WAS DISCHARGED ONE DAY AFTER THE PROCEDURE. 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 8100941

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R