BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1133308 · Received August 22, 2008

    Report

    Report Number
    2024168-2008-00704
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 25, 2008
    Manufacturer
    ABBOTT VASCULAR-VARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - DISSECTION IS LISTED IN THE IFU AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. THIS KNOWN PATIENT EFFECT IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. DISSECTION CAN BE INFLUENCED BY SEVERAL FACTORS, INCLUDING BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. THE IFU ALSO STATES THAT "IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENT AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION. IN THIS CASE, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED DISSECTION AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION, REPORTING RATIONALE: DISSECTION REQUIRING MEDICAL INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE. DEVICE ISSUE: NONE. IT WAS REPORTED VIA THE SPIRIT TRIAL THAT THE XIENCE V WAS DEPLOYED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) AND A DISSECTION OCCURRED, WHICH WAS REQUIRED TREATMENT WITH AN ADDITIONAL XIENCE V STENT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-VARDIAC THERAPIES NA 71203P8

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention