BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1961909 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00329
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    November 6, 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 THAT THE PATIENT HAD A 3.0 X 15 MM XIENCE IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA) ON (B)(6) 2008. ON (B)(6) 2009, THE PATIENT RETURNED WITH FOCAL IN-STENT RESTENOSIS. TREATMENT WAS PERFORMED WITH AN UNSPECIFIED BALLOON AT 20 ATMOSPHERES WITH A GOOD FINAL RESULT. THE PATIENT WAS DISCHARGED THE NEXT DAY. 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