BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1914244 · Received December 3, 2010

    Report

    Report Number
    2024168-2010-02587
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    November 7, 2010
    Report Date
    November 8, 2010
    Manufacturer
    AV-CLONMEL
    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. 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 THE PROCEDURE IN THE LEFT ANTERIOR DESCENDING ARTERY, PRE-DILATATION WAS PERFORMED USING AN RX VOYAGER DILATATION CATHETER. DURING DEPLOYMENT OF THE 4.0 X 15 XIENCE V STENT, A DISSECTION WAS NOTED AT THE DISTAL END OF THE STENT. A 3.5 X 12 XIENCE V STENT WAS DEPLOYED TO COVER THE DISSECTION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA.

    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-CLONMEL 0040141

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention DIL CATH: RX VOYAGER