BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2020760 · Received March 16, 2011

    Report

    Report Number
    2024168-2011-01774
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    November 20, 2009
    Report Date
    March 22, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. DISSECTION 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2009 THE PATIENT UNDERWENT STENTING IN THE PROXIMAL RIGHT CORONARY ARTERY WITH ONE 4.0 X 18 XIENCE V STENT. DURING THE PROCEDURE, THE PATIENT WAS FOUND TO HAVE A SMALL PROXIMAL EDGE DISSECTION WHICH WAS TREATED WITH A 4.0 X 8 XIENCE V STENT. THE CONDITON RESOLVED ON (B)(6) 2009 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 9042261

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention