BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1804069 · Received August 11, 2010

    Report

    Report Number
    2024168-2010-01642
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 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
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE XIENCE V 3.0 X 23 (PART 1009529-23, LOT 9061941) INDICATED WAS FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE REPORTED THROMBOSIS IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING AND IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, 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 #2 ISSUE: NONE. TIME OF DEVICE ISSUE: AFTER THE PROCEDURE. ADVERSE EVENT: THROMBOSIS REQUIRING MEDICAL INTERVENTION. TIME OF ADVERSE EVENT: AFTER THE PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE OCCURRED AT UNIVERSITY MALAYA MEDICAL CENTER IN MALAYSIA. IT WAS REPORTED THAT THE XIENCE V 3.0 X 23 STENT WAS NOTED TO BE FRACTURED DURING THE ANGIOGRAM THAT WAS PERFORMED ON (B)(6) 2010. ON (B)(6) 2009, THE XIENCE V 3.0 X 23 STENT WAS DEPLOYED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND A XIENCE V 2.75 X 28 STENT WAS DEPLOYED IN THE MID RIGHT CORONARY ARTERY (RCA). NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THE REVIEW OF ANGIOGRAPHIC IMAGES REVEALED THAT THERE WAS THROMBOSIS IN THE RCA FROM THE PROXIMAL SEGMENT TO THE MID DISTAL SEGMENT. THE THROMBOSIS WAS TREATED WITH AN ADDITIONAL STENT AND BALLOON INFLATIONS.

    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 60 YR Hospitalization| R XIENCE V 3.0 X 23 (PART 1009529-23, LOT 9061941)