BEUDAMED
    FDA Adverse Event Death Summary report: N

    G2 FILTER SYSTEM - FEMORAL

    MDR report key: 11656100 · Received April 13, 2021

    Report

    Report Number
    2020394-2021-80299
    Event Type
    Death
    Date Received
    April 13, 2021
    Report Date
    May 20, 2021
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K062887
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. APPROXIMATELY 10 YEARS AND TEN MONTHS AFTER DEPLOYMENT, COMPUTED TOMOGRAPHY OF ABDOMEN WITH INTRAVENOUS CONTRAST CONFIRMED THAT THERE WAS A COMPLETE PENETRATION OF THE INFERIOR VENA CAVA FILTER IN THE CAVAL WALL WITH A SINGLE LEG ENTERED THE AORTA. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR PERFORATION OF THE INFERIOR VENA CAVA (IVC). HOWEVER, THE INVESTIGATION IS INCONCLUSIVE FOR FILTER MIGRATION.BASED UPON 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. H10: G3 H11: H6(RESULT AND CONCLUSION) 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. AT SOME TIME, POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER MIGRATED AND STRUTS PERFORATED. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE PATIENT REPORTEDLY EXPIRED.

    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. 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. AT SOME TIME, POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER MIGRATED AND STRUTS PERFORATED. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE PATIENT REPORTEDLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553644 G2 FILTER SYSTEM - FEMORAL VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ALPRAZOLAM, DIAZEPAM, FLUOXETINE| ALPRAZOLAM, DIAZEPAM, FLUOXETINE| CYCLOBENZAPRINE, CLONIDINE, CYMBALTA| CYCLOBENZAPRINE, CLONIDINE, CYMBALTA| PERCOCET, FIORICET, ZOFRAN, AND XARELTO| PERCOCET, FIORICET, ZOFRAN, AND XARELTO| PREDNISONE, VALIUM, LISINOPRIL, FLEXERIL, XANAX| PREDNISONE, VALIUM, LISINOPRIL, FLEXERIL, XANAX| ALPRAZOLAM, DIAZEPAM, FLUOXETINE| CYCLOBENZAPRINE, CLONIDINE, CYMBALTA| PERCOCET, FIORICET, ZOFRAN, AND XARELTO| PREDNISONE, VALIUM, LISINOPRIL, FLEXERIL, XANAX