BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDIS TRAPEASE IVC FILTER

    MDR report key: 14111254 · Received April 13, 2022

    Report

    Report Number
    MW5108965
    Event Type
    Injury
    Date Received
    April 13, 2022
    Date of Event
    April 8, 2022
    Report Date
    April 11, 2022
    Manufacturer
    CORDIS US CORP.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD CORDIS TRAPEASE IVC FILTER PLACED WHICH WAS FOUND TO BE FRACTURED (B)(6) 2022 WITH ASSOCIATED IVC STENOSIS REQUIRING STENTING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2415872 CORDIS TRAPEASE IVC FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK CORDIS US CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention