BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1241101 · Received November 21, 2008

    Report

    Report Number
    2024168-2008-01197
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 22, 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
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING DETERMINED THAT DISSECTION, AS LISTED IN THE IFU, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING AND NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. 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." HOWEVER, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/ MEDICAL INTERVENTION. REPORTING RATIONALE: DISSECTION REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT A DISSECTION OCCURRED DURING DEPLOYMENT OF THE 2.75 X 23MM XIENCE V STENT IN THE LEFT ARTERIOR DESCENDING ARTERY (LAD). TWO ADDITIONAL XIENCE V STENTS WERE USED TO COVER UP THE DISSECTION. 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 7121941

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention DIL CATH: CROSSSAIL| GUIDE CATH: CORDIS| SHEATH: THERMO| STENT: RX XIENCE V (2.75 X 15MM & 2.75 X 18MM)| GUIDE WIRE: BMW