BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2040336 · Received April 5, 2011

    Report

    Report Number
    2024168-2011-02389
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    February 9, 2009
    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
    IL, 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. RESTENOSIS IS A KNOWN ADVERSE EVENT 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. THE 2.75 X 18 XIENCE V, IS BEING FILED UNDER A SEPARATE MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2008 THE PATIENT UNDERWENT A PROCEDURE TO TREAT A LESION IN THE OSTIAL RIGHT CORONARY ARTERY (RCA) DURING WHICH TWO XIENCE V STENT WERE DEPLOYED. ON (B)(6) 2009 THE PATIENT WAS REHOSPITALIZED. ANGIOGRAPHY REVEALED RESTENOSIS IN BOTH THE XIENCE V STENTS. THE RESTENOSIS WAS TREATED WITH THE PLACEMENT OF TWO NON-ABBOTT STENTS. NO ADDITIONAL INFORMATION WAS 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 8052842

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R 2.75 X 18 XIENCE V