BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1962131 · Received January 17, 2011

    Report

    Report Number
    2024168-2011-00345
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 23, 2010
    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. 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 THE PROCEDURE WAS TO TREAT THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD), WHICH WAS TORTUOUS AND CALCIFIED. THE LESION WAS PRE-DILATED WITH A 2.0 X 12 MM BALLOON. WHILE DEPLOYING THE 3.5 X 28 MM XIENCE V, A DISSECTION OCCURRED AT THE DISTAL EDGE OF THE STENT. A 3.0 X 15 MM XIENCE V STENT WAS DEPLOYED TO COVER THE DISSECTION. THERE WAS NO ADVERSE PATIENT SEQUELA AND THE PATIENT WAS DISCHARGED ROUTINELY. 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 0060241

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention GUIDE WIRE: WHISPER ES, GUIDE CATHETER: JL4