BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERIDIAN FILTER SYSTEM - JUGULAR

    MDR report key: 6106572 · Received November 16, 2016

    Report

    Report Number
    2020394-2016-01062
    Event Type
    Death
    Date Received
    November 16, 2016
    Date of Event
    May 7, 2015
    Report Date
    October 21, 2016
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K102511
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDICAL RECORDS AND NO MEDICAL IMAGES WERE PROVIDED TO THE MANUFACTURER. THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE DEVICE IS NOT AVAILABLE FOR RETURN. THE INVESTIGATION 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 HAVE BEEN 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/MICROSCOPIC INSPECTION: AS THE DEVICE WAS NOT RETURNED, AN INSPECTION COULD NOT BE PERFORMED. FUNCTIONAL/PERFORMANCE EVALUATION: AS THE DEVICE WAS NOT RETURNED, AN EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS REVIEW: AS MEDICAL RECORDS WERE NOT PROVIDED, A REVIEW COULD NOT BE PERFORMED. IMAGE/PHOTO REVIEW: AS MEDICAL IMAGES WERE NOT PROVIDED, A REVIEW COULD NOT BE PERFORMED. CONCLUSION: THE DEVICE WAS NOT RETURNED. IMAGES AND MEDICAL RECORDS WERE NOT PROVIDED. THERE WAS NO SPECIFIC DEFICIENCY ALLEGED RELATING TO THE FILTER. THE INVESTIGATION IS INCONCLUSIVE FOR THE ALLEGED PULMONARY EMBOLI POST FILTER DEPLOYMENT. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: POTENTIAL COMPLICATIONS: PROCEDURES REQUIRING PERCUTANEOUS INTERVENTIONAL TECHNIQUES SHOULD NOT BE ATTEMPTED BY PHYSICIANS UNFAMILIAR WITH THE POSSIBLE COMPLICATIONS. COMPLICATIONS MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE. POSSIBLE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: - ACUTE OR RECURRENT PULMONARY EMBOLISM. THIS HAS BEEN REPORTED DESPITE FILTER USAGE. IT IS NOT KNOWN IF THROMBI PASSED THROUGH THE FILTER, OR ORIGINATED FROM SUPERIOR OR COLLATERAL VESSELS. (B)(4). 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 APPROXIMATELY TWO YEARS POST VENA CAVA FILTER DEPLOYMENT FOR PENDING ORTHOPEDIC SURGERY, THE PATIENT WAS SEEN IN THE EMERGENCY DEPARTMENT AND ADMITTED TO THE HOSPITAL. THE FOLLOWING DAY THE PATIENT EXPIRED AS A RESULT OF BILATERAL PULMONARY EMBOLUS. TWO WEEKS LATER, AN AUTOPSY ALLEGEDLY DETERMINED THERE WAS CLOT BURDEN IN THE IVC FILTER AND BILATERAL OCCLUSIONS OF PULMONARY EMBOLUS IN THE PULMONARY ARTERIES. NO OTHER PERTINENT PATIENT OR MEDICAL INFORMATION REGARDING THIS EVENT WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY TWO YEARS POST VENA CAVA FILTER DEPLOYMENT FOR PENDING ORTHOPEDIC SURGERY, THE PATIENT WAS SEEN IN THE EMERGENCY DEPARTMENT AND ADMITTED TO THE HOSPITAL. THE FOLLOWING DAY THE PATIENT EXPIRED AS A RESULT OF BILATERAL PULMONARY EMBOLUS. TWO WEEKS LATER, AN AUTOPSY ALLEGEDLY DETERMINED THERE WAS CLOT BURDEN IN THE IVC FILTER AND BILATERAL OCCLUSIONS OF PULMONARY EMBOLUS IN THE PULMONARY ARTERIES. NO OTHER PERTINENT PATIENT OR MEDICAL INFORMATION REGARDING THIS EVENT WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756812 MERIDIAN FILTER SYSTEM - JUGULAR VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFWL2938

    Patients

    Seq Age Sex Outcome Treatment
    1 Death