BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1251686 · Received December 2, 2008

    Report

    Report Number
    2024168-2008-01265
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 6, 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 - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT. DISSECTION, AS LISTED IN THE XIENCE V IFU, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH STENTING AND IS NOT NECESSARILY AN INDICATION OF A QUALITY ISSUE. DISSECTION CAN BE INFLUENCED BY FACTORS, INCLUDING BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. THE IFU ALSO STATES, "IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION (CABG, FURTHER DILATATION, PLACEMENT OF ADDITIONAL STENTS)" POST DILATATION MAY BE RELATED TO THE REPORTED DISSECTION; HOWEVER, A ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY- MEDICAL INTERVENTION. REPORTING RATIONALE: DISSECTION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT A XIENCE V STENT WAS PLACED IN THE MID LEFT CIRCUMFLEX AND AFTER THE STENT WAS POST DILATED, A DISTAL DISSECTION WAS NOTED. A 2.5X18MM XIENCE V STENT AND A 2.5 X 12MM XIENCE STENT WERE USED TO TREAT THE DISSECTION. NO ADDITIONAL EVENT OR PT INFO 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention