BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECOVERY FILTER SYSTEM

    MDR report key: 6004044 · Received October 6, 2016

    Report

    Report Number
    2020394-2016-00930
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    August 23, 2016
    Report Date
    September 13, 2016
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K031328
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS REPORTED VIA MEDWATCH REPORT #330140-2016-11. THE LOT NUMBER ON THE MEDWATCH WAS REPORTED TO BE 07LN2027; HOWEVER, THE REPORTED LOT NUMBER WAS NOT AN ACCURATE C.R. BARD- GFO LOT NUMBER; THEREFORE, THE CORPORATE LOT NUMBER WILL BE REPORTED AS 'UNKNOWN'. NO DEVICE, NO MEDICAL RECORDS, AND NO MEDICAL IMAGES WERE PROVIDED TO THE MANUFACTURER. THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, MANUFACTURING PROCESS AND QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY EVENT REPORTED TO DATE FOR THIS LOT NUMBER AND FAILURE MODE. VISUAL INSPECTION AND FUNCTIONAL/PERFORMANCE EVALUATION: THE DEVICE WAS NOT RETURNED; THEREFORE, NO VISUAL INSPECTION OR FUNCTIONAL TESTING OF THE DEVICE WAS PERFORMED. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. IMAGE/PHOTO REVIEW: IMAGES/PHOTOS WERE NOT PROVIDED FOR REVIEW. CONCLUSION: THE DEVICE WAS NOT RETURNED. IMAGES AND MEDICAL RECORDS WERE NOT PROVIDED. THE INVESTIGATION WAS INCONCLUSIVE FOR THE MIGRATION OF THE FILTER. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT WAS UNKNOWN. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS: MOVEMENT OR MIGRATION OF THE FILTER IS A KNOWN COMPLICATION. THIS MAY BE CAUSED BY PLACEMENT IN THE IVC'S WITH DIAMETERS EXCEEDING THE APPROPRIATE LABELED DIMENSIONS SPECIFIED IN THE IFU. MIGRATIONS OF FILTERS TO THE HEART OR LUNGS HAVE ALSO BEEN REPORTED IN ASSOCIATION WITH IMPROPER DEPLOYMENT, DEPLOYMENT INTO CLOTS AND /OR DISLODGMENT DUE TO LARGE CLOT BURDENS. POSSIBLE COMPLICATIONS INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING: MOVEMENT OR MIGRATION OF THE FILTER IS A KNOWN COMPLICATION. THIS MAY BE CAUSED BY PLACEMENT IN THE IVC'S WITH DIAMETERS EXCEEDING THE APPROPRIATE LABELED DIMENSIONS SPECIFIED IN THE IFU. MIGRATIONS OF FILTERS TO THE HEART OR LUNGS HAVE ALSO BEEN REPORTED IN ASSOCIATION WITH IMPROPER DEPLOYMENT, DEPLOYMENT INTO CLOTS AND /OR DISLODGMENT DUE TO LARGE CLOT BURDENS. ALL OF THE ABOVE COMPLICATIONS HAVE BEEN ASSOCIATED WITH SERIOUS ADVERSE EVENTS SUCH AS MEDICAL INTERVENTION AND/OR DEATH. THE RISK/BENEFIT RATIO OF ANY OF THESE COMPLICATIONS SHOULD BE WEIGHED AGAINST THE INHERENT RISK/BENEFIT RATIO FOR A PATIENT WHO IS AT RISK OF PULMONARY EMBOLISM WITHOUT INTERVENTION. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENA CAVA FILTER ALLEGEDLY DISLODGED AND EMBOLIZED TO THE RIGHT ATRIUM WITH POSSIBLE PERFORATION OF THE RIGHT ATRIUM. THE PATIENT UNDERWENT CARDIAC SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENA CAVA FILTER ALLEGEDLY DISLODGED AND EMBOLIZED TO THE RIGHT ATRIUM WITH POSSIBLE PERFORATION OF THE RIGHT ATRIUM. THE PATIENT UNDERWENT CARDIAC SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655578 RECOVERY FILTER SYSTEM VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. 07LN2027

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| R