BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECLIPSE FILTER SYSTEM - FEMORAL

    MDR report key: 8929824 · Received August 26, 2019

    Report

    Report Number
    2020394-2019-02918
    Event Type
    Death
    Date Received
    August 26, 2019
    Date of Event
    January 19, 2018
    Report Date
    February 12, 2020
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K093659
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING REVIEW: A LOT HISTORY REVIEW WAS PERFORMED. THIS IS THE ONLY COMPLAINT TO DATE FOR THIS LOT NUMBER. THEREFORE, A DEVICE HISTORY RECORD (DHR) REVIEW IS NOT REQUIRED. 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 TWO YEARS LATER, PATIENT WAS IMPLANTED WITH ANOTHER BARD ECLIPSE VENA CAVA FILTER IN THE INFRA RENAL LOCATION DUE TO DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM. APPROXIMATELY THREE YEARS POST FILTER DEPLOYMENT, CT REVEALED THE FILTER STRUTS PENETRATED THROUGH THE IVC WALL INTO THE PERICAVAL/MESENTERIC FAT. APPROXIMATELY, 10MONTHS LATER, PATIENT EXPIRED. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR PERFORATION OF THE IVC.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: B5,D4(EXPIRY DATE: (B)(6) 2017.

    Additional Manufacturer Narrative · 0

    MANUFACTURING REVIEW: A LOT HISTORY REVIEW WAS PERFORMED. THIS IS THE ONLY COMPLAINT TO DATE FOR THIS LOT NUMBER. THEREFORE, A DEVICE HISTORY RECORD (DHR) REVIEW IS NOT REQUIRED. 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 TWO YEARS LATER, PATIENT WAS IMPLANTED WITH ANOTHER BARD ECLIPSE VENA CAVA FILTER IN THE INFRA RENAL LOCATION DUE TO DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM. APPROXIMATELY THREE YEARS POST FILTER DEPLOYMENT, CT REVEALED THE FILTER STRUTS PENETRATED THROUGH THE IVC WALL INTO THE PERICAVAL/MESENTERIC FAT. APPROXIMATELY, 10 MONTHS LATER, PATIENT EXPIRED. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR PERFORATION OF THE IVC.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. (EXPIRY DATE: 02/2017).

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT THE FILTER STRUTS PERFORATED THE IVC WALL EXTENDING INTO THE MESENTERIC FAT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. NEW INFORMATION: IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER STRUTS PERFORATED INTO THE ORGANS. THE DEVICE WAS REMOVED PERCUTANEOUSLY. THE PATIENT REPORTEDLY EXPIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT THE FILTER STRUTS PERFORATED THE IVC WALL EXTENDING INTO THE MESENTERIC FAT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. NEW INFORMATION: IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER STRUTS PERFORATED INTO THE ORGANS. 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 PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRY DATE: 02/2017).

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT THE FILTER STRUTS PERFORATED THE IVC WALL EXTENDING INTO THE MESENTERIC FAT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. NEW INFORMATION: IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER STRUTS PERFORATED INTO THE ORGANS. 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
    723922 ECLIPSE FILTER SYSTEM - FEMORAL VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFYA2840

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death ADVAIR, ZOFRAN, INDERAL, IMITREX| ADVAIR, ZOFRAN, INDERAL, IMITREX| ADVAIR, ZOFRAN, INDERAL, IMITREX| DIAZEPAM, ESCITALOPRAM, FLUPHENAZINE| DIAZEPAM, ESCITALOPRAM, FLUPHENAZINE| DIAZEPAM, ESCITALOPRAM, FLUPHENAZINE| ELIQUIS, LOVENOX, WARFARIN, DUONEB| ELIQUIS, LOVENOX, WARFARIN, DUONEB| ELIQUIS, LOVENOX, WARFARIN, DUONEB| FOLIC ACID, ATIVAN, PROVENTIL, FOSAMAX| FOLIC ACID, ATIVAN, PROVENTIL, FOSAMAX| FOLIC ACID, ATIVAN, PROVENTIL, FOSAMAX| LEVAQUIN, KLOR-CON, PREDNISONE, PROTONIX| LEVAQUIN, KLOR-CON, PREDNISONE, PROTONIX| LEVAQUIN, KLOR-CON, PREDNISONE, PROTONIX| OLANZAPINE, QUETIAPINE, AMITRIPTYLINE| OLANZAPINE, QUETIAPINE, AMITRIPTYLINE| OLANZAPINE, QUETIAPINE, AMITRIPTYLINE| VITAMIN D2, GABAPENTIN, LORAZEPAM, MIRTAZAPINE| VITAMIN D2, GABAPENTIN, LORAZEPAM, MIRTAZAPINE| VITAMIN D2, GABAPENTIN, LORAZEPAM, MIRTAZAPINE| ZOLMITRIPTAN| ZOLMITRIPTAN| ZOLMITRIPTAN| ADVAIR, ZOFRAN, INDERAL, IMITREX| DIAZEPAM, ESCITALOPRAM, FLUPHENAZINE| ELIQUIS, LOVENOX, WARFARIN, DUONEB| FOLIC ACID, ATIVAN, PROVENTIL, FOSAMAX| LEVAQUIN, KLOR-CON, PREDNISONE, PROTONIX| OLANZAPINE, QUETIAPINE, AMITRIPTYLINE| VITAMIN D2, GABAPENTIN, LORAZEPAM, MIRTAZAPINE| ZOLMITRIPTAN