BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENFIELD

    MDR report key: 9946841 · Received April 9, 2020

    Report

    Report Number
    2134265-2020-04888
    Event Type
    Injury
    Date Received
    April 9, 2020
    Date of Event
    March 7, 2019
    Report Date
    July 29, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DTK
    UDI-DI
    08714729114659
    PMA / PMN Number
    K901659
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2006 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019 A COMPUTED TOMOGRAPHY (CT) CAN OF THE ABDOMEN REVEALED TILT AND INJURY. THERE WAS A SLIGHT POSTERIOR TILT OF APPROXIMATELY 2.5 DEGREES. THE APEX OF THE FILTER LIED ALONG THE POSTERIOR INFERIOR VENA CAVA (IVC) WALL. THERE WERE SIX INTACT STRUTS SEEN. THE ANTERIOR STRUT APPEARED TO EXTEND BEYOND THE IVC WALL BY APPROXIMATELY 1MM ANTERIORLY. THE POSTERIOR STRUT QUESTIONABLE EXTENDED 1 TO 2MM. THERE WAS APPARENT SLIGHT EXTENSION OF THE RIGHT STRUT BEYOND THE IVC WALL APPROXIMATELY 2 TO 3MM LATERAL TO RIGHT AS WELL AS ADJACENT STRUT EXTENDING APPROXIMATELY 2 TO 3MM LATERALLY TO THE RIGHT. THERE WAS APPARENT EXTENSION OF POSTERO LATERAL RIGHT STRUT MEASURING APPROXIMATELY 2MM LATERALLY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2006 THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019 A COMPUTED TOMOGRAPHY (CT) CAN OF THE ABDOMEN REVEALED TILT AND INJURY. THERE WAS A SLIGHT POSTERIOR TILT OF APPROXIMATELY 2.5 DEGREES. THE APEX OF THE FILTER LIED ALONG THE POSTERIOR INFERIOR VENA CAVA (IVC) WALL. THERE WERE SIX INTACT STRUTS SEEN. THE ANTERIOR STRUT APPEARED TO EXTEND BEYOND THE IVC WALL BY APPROXIMATELY 1MM ANTERIORLY. THE POSTERIOR STRUT QUESTIONABLE EXTENDED 1 TO 2MM. THERE WAS APPARENT SLIGHT EXTENSION OF THE RIGHT STRUT BEYOND THE IVC WALL APPROXIMATELY 2 TO 3MM LATERAL TO RIGHT AS WELL AS ADJACENT STRUT EXTENDING APPROXIMATELY 2 TO 3MM LATERALLY TO THE RIGHT. THERE WAS APPARENT EXTENSION OF POSTERO LATERAL RIGHT STRUT MEASURING APPROXIMATELY 2MM LATERALLY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409166 GREENFIELD FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK BOSTON SCIENTIFIC CORPORATION 43175 0008896603 08714729114659

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other