BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2182422 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05348
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 4, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED DISSECTION IS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). CINE IMAGES WERE REVIEWED BY ABBOTT CLINICAL AND CONFIRMED THE DISSECTION OCCURRED AFTER THE STENT WAS DEPLOYED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE MILDLY CALCIFIED, DISTAL LEFT ANTERIOR DESCENDING ARTERY, A 3.5 X 15 XIENCE V STENT WAS DEPLOYED AND A DISSECTION OCCURRED. A 3.5 X 18 XIENCE V STENT WAS DEPLOYED FOR TREATMENT OF THE DISSECTION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN 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 0120841

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention