BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1133323 · Received August 22, 2008

    Report

    Report Number
    2024168-2008-00705
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 29, 2008
    Manufacturer
    ABBOTT VASCULAR - CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 FO THE VESSEL REQUIRING ADDITIONAL INTERVENTION (CABG, FURTHER DILATATION, PLACEMENT OF OTHER STENTS OR OTHER.)" A CONCLUSIVE ROOT CAUSE FOR THE REPORTED DISSECTION AND THE RELATIONSHIP OF 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 PERMANENT IMPAIRMENT/DAMAGE. DEVICE ISSUE: NONE. IT WAS REPORTED VIA A SPIRIT TRIAL THAT THE PATIENT PRESENTED WITH TRIPLE VESSEL DISEASE AND TWO LESIONS WERE TREATED. THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE 1ST DIAGONAL. THE MID LAD LESION WAS BEING TREATED WITH A 3.0 X 18 MM XIENCE V STENT AND A DISSECTION OCCURRED. A 3.0 X 08 XIENCE V WAS USED TO SUCCESSFULLY TREAT THE DISSECTION. ANOTHER XIENCE V STENT WAS USED TO TREAT THE SECOND LESION IN THE 1ST DIAGONAL. 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 - CARDIAC THERAPIES NA 71204P8

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention