BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENFIELD

    MDR report key: 9933147 · Received April 7, 2020

    Report

    Report Number
    2134265-2020-04590
    Event Type
    Injury
    Date Received
    April 7, 2020
    Date of Event
    February 1, 2019
    Report Date
    July 28, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DTK
    PMA / PMN Number
    K964284
    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) 2004, THE PATIENT THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A MESENTERIC PERFORATION, DEVICE TILT, AND STRUT BENDING. THERE WERE 13 DEGREES OF LEFT LATERAL TILT AND 12 DEGREES OF POSTERIOR TILT. SEVERAL OF THE STRUTS APPEARED BENT WITHOUT FRACTURE. ONE STRUT PERFORATED 3MM BEYOND THE INFERIOR VENA CAVA (IVC) WALL AND ANOTHER STRUT PERFORATED 2MM BEYOND THE IVC WALL. ON (B)(6) 2020, THE FILTER WAS REMOVED AS IT WAS MIGRATING TOWARDS THE KIDNEY. THE FILTER WAS INTACT UPON REMOVAL.

    Additional Manufacturer Narrative · 1

    PARTIAL LOT NUMBER OF 6864237 WAS REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2004, THE PATIENT THE PATIENT UNDERWENT PLACEMENT OF A GREENFIELD VENA CAVA FILTER. ON (B)(6) 2019, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A MESENTERIC PERFORATION, DEVICE TILT, AND STRUT BENDING. THERE WERE 13 DEGREES OF LEFT LATERAL TILT AND 12 DEGREES OF POSTERIOR TILT. SEVERAL OF THE STRUTS APPEARED BENT WITHOUT FRACTURE. ONE STRUT PERFORATED 3MM BEYOND THE INFERIOR VENA CAVA (IVC) WALL AND ANOTHER STRUT PERFORATED 2MM BEYOND THE IVC WALL. ON (B)(6) 2020, THE FILTER WAS REMOVED AS IT WAS MIGRATING TOWARDS THE KIDNEY. THE FILTER WAS INTACT UPON REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396354 GREENFIELD FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK BOSTON SCIENTIFIC CORPORATION 43335 0006864237

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention