BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENA CAVA FILTER

    MDR report key: 10674152 · Received October 13, 2020

    Report

    Report Number
    2020394-2020-20098
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Date of Event
    July 21, 2017
    Report Date
    December 28, 2020
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE MEDICAL RECORDS INCLUDED IMAGES. THE IMAGE REVIEW WAS DOCUMENTED IN THE MEDICAL RECORDS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. APPROXIMATELY FOUR YEARS LATER, COMPUTED TOMOGRAPHY (CT) REVEALED THAT THERE WERE TWO FILTERS. THE SUPERIOR FILTER: THE SUPERIOR EXTENT OF THE INFERIOR VENA CAVA FILTER AT L1-L2 DISC SPACE. INFERIOR EXTENT AT MID L3 VERTEBRAL BODY. A TOTAL OF 12 PRONGS HAVE PENETRATED INFERIOR VENA CAVA AND MAXIMUM DISTANCE PRONGS PERFORATED WAS 3.59 MM. IN CORONAL IMAGES 5.92-DEGREE TILT LEFT TO RIGHT. INFERIOR FILTER: SUPERIOR EXTENT OF FILTER AT SUPERIOR L2 VERTEBRAL BODY AND INFERIOR EXTEND MID INFERIOR L3 VERTEBRAL BODY. A TOTAL OF 12 PRONGS HAVE PENETRATED THE INFERIOR VENA CAVA AND MAXIMUM DISTANCE PRONGS PERFORATED WAS 4.09 MM. IN CORONAL IMAGES 3.18-DEGREE TILT LEFT TO RIGHT. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR ALLEGED PERFORATION OF THE INFERIOR VENA CAVA (IVC).BASED ON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTS (E.G. PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, AND UNIT LABEL) SHOWED THAT THE PRODUCT LABELING IS ADEQUATE. H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS. APPROXIMATELY FOUR YEARS POST FILTER DEPLOYMENT, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT THE FILTER STRUTS PERFORATED. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, HOWEVER, MEDICAL RECORDS WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS. APPROXIMATELY FOUR YEARS POST FILTER DEPLOYMENT, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT THE FILTER STRUTS PERFORATED. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140131 VENA CAVA FILTER VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other