BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2040254 · Received April 5, 2011

    Report

    Report Number
    2024168-2011-02381
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    February 13, 2011
    Report Date
    March 11, 2011
    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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA 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 THAT ON (B)(6) 2007 THE PATIENT UNDERWENT STENTING IN THE MID RIGHT CORONARY ARTERY (RCA) WITH ONE XIENCE V STENT. ON (B)(6) 2011 THE PATIENT WAS RE-ADMITTED FOR ANGINA. AN ATTEMPT TO REVASCULARIZE THE PROXIMAL RCA WAS MADE, BUT WAS UNSUCCESSFUL AS THE GUIDE WIRE WAS UNABLE TO CROSS THE 100% STENOSED LESION. THE ANGINA RESOLVED ON (B)(6) 2011 UPON DISCHARGE. 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 61215P1

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R| S