BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1132124 · Received August 21, 2008

    Report

    Report Number
    2024168-2008-00696
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 28, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - DISSECTION IS LISTED IN THE IFU AND RISK ASSESSMENT AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. THIS PT EFFECT IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. THERE WAS NO REPORT OF A DEVICE MALFUNCTION. DISSECTION CAN BE INFLUENCED BY SEVERAL FACTORS 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 OTHER STENTS OR OTHER)" 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: NONE. IT WAS REPORTED THAT TREATMENT WAS PLANNED FOR TWO LESIONS, THE PROXIMAL LAD AND THE PROXIMAL RCA. A 3.5 X 18 MM XIENCE V STENT WAS PLACED IN THE PROXIMAL LAD. A DISSECTION OCCURRED DISTAL TO THE STENT WHICH REQUIRED PLACEMENT OF ANOTHER 3.0 X 8 MM XIENCE V STENT, AS A BAILOUT STENT. THE PROCEDURE WAS COMPLETED WITH THE DEPLOYMENT OF A 2.5 X 18 MM XIENCE V STENT IN THE PROXIMAL RCA. 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 71203P8

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention