BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1231635 · Received November 14, 2008

    Report

    Report Number
    2024168-2008-01155
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    September 26, 2008
    Report Date
    October 15, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION: PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT. DISSECTION, LISTED IN THE XIENCE IFU, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING AND IS NOT 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 DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENT AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION (CABG, FURTHER DILATATION, PLACEMENT OF ADDITIONAL STENTS, OR OTHER)." A CONCLUSIVE ROOT CAUSE FOR THE PATIENT EFFECT, AND RELATIONSHIP TO THE DEVICE, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: DISSECTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA TRIAL THAT THE PATIENT WAS EXPERIENCING ANGINA. PRE-DILATATION WAS PERFORMED IN THE PROX LAD. DURING DEPLOYMENT OF THE FIRST XIENCE V STENT IN THE PROXIMAL LAD, A DISSECTION OCCURRED DISTAL TO THE TARGET LESION. ANTHER XIENCE V STENT WAS USED AS A BAILOUT STENT, AND THE DISSECTION WAS TREATED SUCCESSFULLY. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention