BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1760551 · Received July 15, 2010

    Report

    Report Number
    2024168-2010-01401
    Event Type
    Injury
    Date Received
    July 15, 2010
    Date of Event
    June 21, 2010
    Report Date
    June 21, 2010
    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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): THROMBOSIS IS A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A 100% VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: SUBACUTE STENT THROMBOSIS (SAT). TIME OF ADVERSE EVENT: 28 DAYS POST STENT DEPLOYMENT. IT WAS REPORTED THAT A 3.5 X 15 XIENCE V STENT WAS DEPLOYED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND A 3.5 X 28 XIENCE V STENT WAS DEPLOYED IN THE MID RCA DURING THE SAME PROCEDURE ON (B) (6)2010. THE TWO STENTS WERE POST DILATED WITH A 2.5 X 15 NC VOYAGER AND THE PROCEDURE WAS COMPLETED WITHOUT AN ISSUE. HOWEVER, ON (B) (6)2010, THE PATIENT RETURNED TO HAVE THE LEFT ANTERIOR DESCENDING ARTERY VESSEL TREATED. DURING THIS PROCEDURE, INTRAVASCULAR ULTRA SOUND (IVUS) WAS USED AND THE PHYSICIAN DECIDED TO CHECK ON THE STENTS THAT WERE PREVIOUSLY DEPLOYED IN THE RCA. IVUS REVEALED THROMBOSIS IN THE 3.5 X 15 XIENCE V STENT. THE XIENCE V IN THE MID RCA LOOK PATENT. REPORTEDLY, FLOW WAS GOOD IN THE PROXIMAL RCA, BUT IT WAS DECIDED TO TREAT THE THROMBOSIS. FIRST ASPIRATION WAS ATTEMPTED, BUT THE ASPIRATION CATHETER COULD NOT CROSS THE PROXIMAL RCA. A 3.5 X 15 NC VOYAGER BALLOON CATHETER WAS USED TO TREAT THE SAT WITH GOOD RESULTS. 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 58 YR Required Intervention