BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT STYSTEM

    MDR report key: 1253516 · Received December 5, 2008

    Report

    Report Number
    2024168-2008-01293
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    November 4, 2008
    Report Date
    November 18, 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
    GM
    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 IFC, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH STENTING. DISSECTION IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. NO DEVICE MALFUNCTION WAS REPORTED. DISSECTION CAN BE INFLUENCED BY SEVERAL 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 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,...)." A CONCLUSIVE 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 AFTER IMPLANT OF A 3.0 X 18 MM XIENCE V STENT IN THE PROXIMAL CIRCUMFLEX, A DISSECTION WAS NOTED. THE DISSECTION WAS TREATED BY IMPLANTING ANOTHER DRUG ELUTING 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 STYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention