BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1243769 · Received November 24, 2008

    Report

    Report Number
    2024168-2008-01220
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    October 29, 2008
    Report Date
    October 30, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT. DISSECTION IS LISTED IN THE IFU AS AN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING AND IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. THERE WAS NO REPORT OF A DEVICE MALFUNCTION. DISSECTION CAN BE INFLUENCED BY LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. THE IFU STATES "IMPLANTING A STENT MAY LEAD TO VESSEL DISSECTION AND ACUTE CLOSURE REQUIRING ADDITIONAL INTERVENTION (CABG, FURTHER DILATATION, PLACEMENT OF ADDITIONAL STENTS, OR OTHER)." A CONCLUSIVE ROOT CAUSE FOR THE REPORTED DISSECTION AND THE RELATIONSHIP TO THE DEVICE 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 THAT THE FIRST XIENCE V WAS ADVANCED TO THE LESION, AND DURING DEPLOYMENT OF THE STENT, A PROXIMAL DISSECTION OCCURRED. AN ADDITIONAL XIENCE V STENT WAS ADVANCED TO TREAT THE DISSECTION; HOWEVER, IT FAILED TO CROSS AND DURING REMOVAL, THE STENT CAUGHT ON THE PREVIOUSLY DEPLOYED STENT, AND DISLODGED FROM THE BALLOON. A SNARE DEVICE WAS USED TO RETRIEVE THE STENT FROM THE PATIENT. THE PROCEDURE WAS CONTINUED SUCCESSFULLY WITH THE DEPLOYMENT OF ANOTHER XIENCE V STENT FOR TREATMENT OF THE DISSECTION, WITH NO FURTHER ISSUES. 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 8051761

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention