BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITANIUM GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM

    MDR report key: 1920135 · Received December 10, 2010

    Report

    Report Number
    2134265-2010-05636
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    DTK
    PMA / PMN Number
    K901659
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AGE AT TIME OF EVENT: 70 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEEP VEIN THROMBOSIS TREATMENT PROCEDURE, FILTER DEPLOYMENT ISSUES OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT INTERNAL JUGULAR ARTERY. THE TARGET LESION WAS LOCATED IN THE INFAR REAL OF THE VENA CAVA ARTERY. THE 12 FR JUGULAR TITANIUM FILTER WAS ADVANCED AND DEPLOYED. HOWEVER, DEPLOYMENT ISSUES OCCURRED AND ONLY 3 OR 4 OF THE FILTER LEGS ATTACHED TO THE VESSEL WALL. NO FILTER MIGRATION OCCURRED. ADDITIONAL PLACEMENT OF A SECOND FILTER WAS UNNECESSARY AS THE PHYSICIAN BELIEVES THE PATIENT IS ADEQUATELY PROTECTED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITANIUM GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK BOSTON SCIENTIFIC - CORK M001503000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other