BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2040312 · Received April 5, 2011

    Report

    Report Number
    2024168-2011-02385
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 11, 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
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A GRAFTMASTER WAS SELECTED FOR COMPASSIONATE USE FOR TREATMENT OF A RIGHT CORONARY OSTIAL RESTENOSIS OF A 4.0 X 15 XIENCE V STENT IMPLANTED ON (B)(6) 2011. THE GRAFTMASTER WAS USED SUCCESSFULLY FOR TREATMENT OF THE RESTENOSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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 0081141

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R