BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECLIPSE FILTER SYSTEM - FEMORAL

    MDR report key: 12603705 · Received October 11, 2021

    Report

    Report Number
    2020394-2021-80731
    Event Type
    Death
    Date Received
    October 11, 2021
    Date of Event
    January 17, 2018
    Report Date
    October 11, 2021
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K093659
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    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. 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, SEVEN YEARS SIX MONTHS OF POST DEPLOYMENT, COMPUTERIZED TOMOGRAPHY-ABDOMEN WAS REVEALED THAT, SUPERIOR EXTENT OF INFERIOR VENA CAVA FILTER L2-L3 DISC SPACE. INFERIOR EXTENT L3-L4 DISC SPACE. A TOTAL OF FIVE PRONGS HAD PERFORATED THE INFERIOR VENA CAVA SERIES 2 IMAGE 53. MAXIMUM DISTANCE PRONGS PERFORATED 9 MM SERIES 2 IMAGE 53. CORONA! IMAGES 5-DEGREE TILT LEFT TO RIGHT SERIES 602 IMAGE 36. SAGITTAL IMAGES 0-DEGREE TILT SERIES 603 IMAGE 52. DIAMETER OF INFERIOR VENA CAVA DIRECTLY ABOVE FILTER 23 MM X 19 MM SERIES 2 IMAGE 45. THE PATIENT REPORTEDLY EXPIRED. BASED ON THE DEATH CERTIFICATE RECEIVED, AROUND, TWO YEARS AND TWENTY FOUR DAYS LATER, PATIENT DIED DUE TO UNKNOWN REASON. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE PERFORATION OF THE INFERIOR VENA CAVA (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: 02/2013).

    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/PULMONARY EMBOLISM. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER PERFORATED THE AORTA (GRADE IV IVC PERFORATION). 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
    1507310 ECLIPSE FILTER SYSTEM - FEMORAL VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFUA4101

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death