BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1961892 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00324
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    February 16, 2010
    Report Date
    December 20, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 18 (PART# 1009539-18, LOT# UNKNOWN). THE XIENCE V 2.5 X 18 (PART# 1009539-18, LOT# UNKNOWN) IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). 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 APPROXIMATELY SIXTEEN MONTHS POST XIENCE V STENT IMPLANTATION IN THE FIRST OBTUSE MARGINAL ARTERY (1ST OM ) (2.5 X 18 MM) AND IN THE PROXIMAL CIRCUMFLEX ARTERY (PCX) (2.5 X 15 MM), THE PATIENT EXPERIENCED INCREASING INTENSITY AND FREQUENCY OF CHEST PAIN. ON (B)(6) 2010 THE PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT FOR 100% OCCLUSION IN THE 1ST OM AND A 30% OSTIAL STENOSIS IN THE PCX. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2010. ALTHOUGH 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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| S CONCOMITANT MEDICAL DEVICES