BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1982733 · Received February 9, 2011

    Report

    Report Number
    2024168-2011-00783
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    December 13, 2010
    Report Date
    January 17, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE STENT REMAINS INSIDE THE PATIENT. 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 THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2010 THE PATIENT UNDERWENT STENTING IN THE PRE-DILATED PROXIMAL LEFT CIRCUMFLEX ARTERY WITH ONE 2.75 X 15 MM XIENCE V STENT. ON (B)(6) 2010, THE PATIENT WAS FOUND TO HAVE STABLE ANGINA, A (B)(4) STUDY, AND IN-STENT RESTENOSIS IN THE INDEX TARGET LESION. ON (B)(6) 2010, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PTCI) TO TREAT THE RESTENOSIS. THE EVENT RESOLVED ON (B)(6) 2010 AND THE PATIENT WAS DISCHARGED. 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 0010642

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R