BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 2061178 · Received April 18, 2011

    Report

    Report Number
    2134265-2011-01348
    Event Type
    Death
    Date Received
    April 18, 2011
    Date of Event
    February 12, 2011
    Report Date
    March 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    DTK
    PMA / PMN Number
    K901659
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH REPORT NUMBER: (B)(4). RESPONSE TO FDA REQUEST: QUESTION 1. THE FINAL RESULTS OF ANY FAILURE ANALYSIS OR LABORATORY TESTING OF THE DEVICE LISTED IN THE REPORTS(S) INCLUDING: (1) A COMPLETE DESCRIPTION OF METHODOLOGY(IES) USED, (2) AN IDENTIFICATION OF THE FAILURE MODE(S) AND/OR MECHANISM(S) AND THE ASSOCIATED COMPONENT(S) INVOLVED, (3) ANY CONCLUSIONS BASED ON THE FINAL FAILURE ANALYSIS OR LABORATORY TEST RESULTS. RESPONSE: THIS DEVICE WAS DEPLOYED AND LODGED IN THE PATIENT AND WAS NOT REMOVED BEFORE THE PATIENT'S DEATH; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. PER THE DFU, THE ACTION SUGGESTED TO ADDRESS THIS CONDITION IS: "DO NOT ATTEMPT TO MOVE OR MANIPULATE AN ENGAGED FILTER. IN MOST CASES, A SECOND FILTER PROPERLY PACED SHOULD BE IMPLANTED FOR PROTECTION AGAINST RECURRENT PE." THE DFU ALSO CONTAINS THE FOLLOWING CAUTION, "INSUFFICIENT FLUSHING CAN ALLOW THROMBUS FORMATION INSIDE THE TITANIUM GREENFIELD VENA CAVA FILTER WHICH CAN BIND THE LEGS AND PREVENT COMPLETE OPENING UPON RELEASE." THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL AND/OR PROCEDURAL FACTORS. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED VIA VOLUNTARY MEDWATCH (B)(4) THAT DURING A FILTER PLACEMENT PROCEDURE, A DEPLOYMENT ISSUE OCCURRED. THE LESION WAS LOCATED IN THE INFERIOR VENA CAVA ARTERY (IVC). THE PHYSICIAN ADVANCED THE 12FR/4.0MM TITANIUM GREENFIELD VENA CAVA FILTER TO THE LESION AND UPON PLACEMENT THE FILTER FAILED TO DEPLOY AND MIGRATED TO THE SUPERIOR VENA CAVA ARTERY (SVC). THE PHYSICIAN ATTEMPTED TO RETRIEVE THE FILTER AND DURING RETRIEVAL THE FILTER DEPLOYED AND LODGED IN THE SVC. THE PHYSICIAN THEN DEPLOYED ANOTHER 12FR/4.0MM TITANIUM GREENFIELD VENA CAVA FILTER IN THE IVC. THE PHYSICIAN PLANNED TO REMOVE THE FIRST FILTER AT A LATER TIME. THE PATIENT STATUS WAS STABLE FOR TWENTY-FOUR TO THIRTY-SIX HOURS POST PROCEDURE AND THEN THE PATIENT'S HYPERTENSION "STARTED TO GET OUT OF CONTROL". HYPERTENSION MEDICATION WAS INCREASED AND MAY HAVE "HIDDEN SOME SYMPTOMS". THE PATIENT EXPIRED FOUR DAYS POST INITIAL PROCEDURE. AUTOPSY WAS PERFORMED BUT AN OFFICIAL CAUSE OF DEATH WAS NOT RECEIVED; HOWEVER PER THE HOSPITAL RISK MANAGER THE DEATH IS BELIEVED TO BE RELATED TO THIS EVENT AS "IT APPEARS THAT THERE WAS BLEEDING INTO THE PERICARDIUM SACK".

    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 M001503010 0013213515

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death