BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2113381 · Received June 3, 2011

    Report

    Report Number
    2024168-2011-03868
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. THE STENT REMAINS IN THE PATIENT. 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 THAT DURING IMPLANTATION OF THE 3.5 X 15 MM XIENCE V STENT IN THE PRE-DILATED, MODERATELY TORTUOUS AND MODERATELY CALCIFIED TARGET LESION IN THE MID LEFT CIRCUMFLEX ARTERY, A PROXIMAL EDGE DISSECTION OCCURRED. A 3.5 X 12 MM XIENCE V STENT WAS IMPLANTED TO SEAL THE EDGE DISSECTION. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PATIENT WAS DISCHARGED HOME ROUTINELY. 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 0101941

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention GUIDE WIRE: WHISPER ESGUIDE CATH: JL4