BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1961588 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00297
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    November 13, 2009
    Report Date
    December 21, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2008. THREE XIENCE V STENTS WERE DEPLOYED, ONE IN THE OSTIAL RIGHT CORONARY ARTERY (RCA), AND TWO IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PROCEDURE WAS SUCCESSFUL. ON (B)(6) 2009, PROXIMAL EDGE STENT RESTENOSIS WAS NOTED IN THE STENT PLACED IN THE OSTIAL RCA, WHICH REQUIRED TREATMENT WITH AN ADDITIONAL STENT. THE PATIENT WAS DISCHARGED ON (B)(6) 2009. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R