BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENATECH LP

    MDR report key: 12239137 · Received July 28, 2021

    Report

    Report Number
    9612452-2021-00036
    Event Type
    Injury
    Date Received
    July 28, 2021
    Date of Event
    August 4, 2014
    Report Date
    July 28, 2021
    Manufacturer
    B.BRAUN MEDICAL SAS
    Product Code
    DTK
    UDI-DI
    04038653918164
    PMA / PMN Number
    K010485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IN THE INITIAL REPORT, THE MODEL#, THE CATALOG " AND THE UDI # WERE GIVEN WHILE IT IS UNKNOW WHICH FILTER WAS IMPLANTED. THIS INFORMATION SHOULD NOT BE TAKEN INTO ACCOUNT.

    Description of Event or Problem · 0

    "FILTER WAS IMPLANTED INTO PATIENT ON OR ABOUT (B)(6), 2010. ON (B)(6), 2018, PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY SCAN ("CT SCAN") OF THE CHEST. EXAMINATION OF THE CT SCAN BY A QUALIFIED EXPERT RADIOLOGIST REVEALED PERFORATION OF ONE (1) OF THE LEFT LEGS OF THE FILTER, EXTENDING APPROXIMATELY 4 MM OUTSIDE THE MARGIN OF THE IVC."

    Additional Manufacturer Narrative · 1

    WITHOUT CONCRETE ELEMENT NOR BATCH INVOLVED, NO THOROUGH INVESTIGATION CAN BE PERFORMED. A CAUSALITY LINK BETWEEN THE DEVICE AND THE REPORTED EVENT CANNOT BE ESTABLISHED. NO CONCLUSION CAN BE DRAWN ABOUT THE EVENT ROOT CAUSE. IF NEW ELEMENTS BECOME AVAILABLE IN THE FUTURE, WE WILL UPDATE THIS CASE. IT IS WORTH NOTING THAT IVC PERFORATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ALL IVC FILTERS AND LISTED IN THE IFU. THE CURRENT IVC PERFORATION RATE FOR VENATECH LP IS VERY LOW. NO ACTION IS ENVISAGED. B.BRAUN MEDICAL SAS IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORTED INCIDENT HAS NOT BEEN SUBSTANTIATED BY ANY VERIFIABLE INFORMATION (E.G. FILMS OR MEDICAL RECORDS) THAT COULD BE USED TO INVESTIGATE THE VERACITY OF THE ALLEGED INCIDENT OR RELATION TO THE DEVICE OR PROCEDURE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR CONCLUSION BY B.BRAUN MEDICAL SAS OR ITS EMPLOYEES THAT THE DEVICE, B.BRAUN MEDICAL SAS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 1

    "FILTER WAS IMPLANTED INTO PATIENT ON OR ABOUT (B)(6) 2010. ON (B)(6) 2018, PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY SCAN ("CT SCAN") OF THE CHEST. EXAMINATION OF THE CT SCAN BY A QUALIFIED EXPERT RADIOLOGIST REVEALED PERFORATION OF ONE (1) OF THE LEFT LEGS OF THE FILTER, EXTENDING APPROXIMATELY 4 MM OUTSIDE THE MARGIN OF THE IVC."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136588 VENATECH LP VENA CAVA FILTER SYSTEM DTK B.BRAUN MEDICAL SAS 31335 UNKNOWN 04038653918164

    Patients

    Seq Age Sex Outcome Treatment
    1 Other