BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE FILTER SYSTEM - FEMORAL

    MDR report key: 8621475 · Received May 17, 2019

    Report

    Report Number
    2020394-2019-00578
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    October 30, 2013
    Report Date
    July 24, 2019
    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. IMAGES WERE NOT PROVIDED FOR REVIEW. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. THE NEXT DAY OF FILTER DEPLOYMENT, PATIENT EXPERIENCED PAIN AND CT SCAN SHOWED PERFORATION OF ONE OF THE LIMBS OF THE FILTER THROUGH THE AORTA. APPROXIMATELY, 3 YEARS LATER, CT REVEALED MULTIPLE FILTER LIMBS PERFORATING THE IVC WALL, ONE LIMB PERFORATING THE ABDOMINAL AORTA. SUBSEQUENTLY, THE FILTER WAS EXPLANTED SUCCESSFULLY. 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: 04/2016).

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT UPON THE FILTER WAS PLACED IN CONJUNCTION WITH OR BEFORE BARIATRIC PROCEDURE. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER PERFORATED AN UNKNOWN LOCATION. THE DEVICE WAS REMOVED PERCUTANEOUSLY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    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. IMAGES WERE NOT PROVIDED FOR REVIEW. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. ONE DAY POST FILTER DEPLOYMENT, PATIENT EXPERIENCED PAIN AND CT SCAN SHOWED PERFORATION OF ONE OF THE LIMBS OF THE FILTER THROUGH THE AORTA. APPROXIMATELY THREE YEARS LATER, CT REVEALED MULTIPLE FILTER LIMBS PERFORATING THE IVC WALL, ONE LIMB PERFORATING THE ABDOMINAL AORTA. SUBSEQUENTLY, THE FILTER WAS EXPLANTED SUCCESSFULLY. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR FILTER PERFORATION. 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: 04/2016).

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT UPON THE FILTER WAS PLACED IN CONJUNCTION WITH OR BEFORE BARIATRIC PROCEDURE. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER PERFORATED AN UNKNOWN LOCATION. THE DEVICE WAS REMOVED PERCUTANEOUSLY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413840 ECLIPSE FILTER SYSTEM - FEMORAL VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFXC3597

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention BUPROPRION, CLONAZEPAM, ERGOCALCIFEROL, GABAPENTIN| BUPROPRION, CLONAZEPAM, ERGOCALCIFEROL, GABAPENTIN| HYFROCHLOROTHIAZIDE, IBUPROFEN, LINZESS, NASONEX| HYFROCHLOROTHIAZIDE, IBUPROFEN, LINZESS, NASONEX| NITROFURANTOIN, PRAZOSIN| NITROFURANTOIN, PRAZOSIN| SUMATRIPTAN, TOPIRAMATE, TRAMADOL, TRAZODONE| SUMATRIPTAN, TOPIRAMATE, TRAMADOL, TRAZODONE| BUPROPRION, CLONAZEPAM, ERGOCALCIFEROL, GABAPENTIN| HYFROCHLOROTHIAZIDE, IBUPROFEN, LINZESS, NASONEX| NITROFURANTOIN, PRAZOSIN| SUMATRIPTAN, TOPIRAMATE, TRAMADOL, TRAZODONE