BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    MDR report key: 6800942 · Received August 17, 2017

    Report

    Report Number
    1820334-2017-02268
    Event Type
    Malfunction
    Date Received
    August 17, 2017
    Date of Event
    April 27, 2017
    Report Date
    August 24, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    UDI-DI
    10827002330174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INVESTIGATION IT WAS CONFIRMED THAT THIS INFORMATION HAS BEEN PREVIOUSLY REPORTED IN MDR#1820334-2016-00327. COOK INC. HAS CANCELED MDR# 1820334-2017-02268 AND WILL BE SUPPLEMENTING ANY ADDITIONAL INFORMATION ON MDR#1820334-2016-00327.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K072240. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Description of Event or Problem · 1

    A GUNTHER TULIP JUGULAR VENA CAVA FILTER SET WAS USED DURING AN IVCC FILTER PLACEMENT. IT WAS REPORTED THAT, THE INFERIOR VENA CAVA (IVC) DIAMETER AT THE INTENDED FILTER LOCATION WAS 17.04 MM. THERE WAS AN IVC ANATOMIC ANOMALY (ACCESSORY LEFT RENAL VEIN), BUT NO PRESENCE OF THROMBUS IN THE IVC PRIOR TO FILTER PLACEMENT. USING THE RIGHT INTERNAL JUGULAR VEIN AS THE ACCESS SITE, A GÜNTHER TULIP® FILTER WAS DEPLOYED AT THE INTENDED LOCATION IN THE IVC SUPRARENAL SITE AND IN A LOCATION SUITABLE TO PROVIDE SUFFICIENT MECHANICAL PROTECTION AGAINST PE. THE FILTER NEITHER DEPLOYED PREMATURELY NOR DID THE FILTER JUMP UPON DEPLOYMENT. THERE WAS NO EVIDENCE OF FILTER FRACTURE, DEFORMATION, MIGRATION, FILTER LEGS APPEARING OUTSIDE THE COLUMN OF CONTRAST, OR EXTRAVASATION OF CONTRAST AFTER FILTER PLACEMENT. THE FILTER ANGLE OF TILT WAS 11 - <16 DEGREES. CORE LAB ANALYSIS OF THE PLACEMENT PROCEDURE VENACAVAGRAM REVEALED NO IVC ANATOMIC ANOMALY OR PRESENCE OF THROMBUS IN THE IVC PRIOR TO FILTER PLACEMENT. THE FILTER WAS PLACED IN THE IVC INFRARENAL SITE, AND THE IVC DIAMETER AT THE FILTER LOCATION WAS 17.3 MM. THERE WAS NO EVIDENCE OF FILTER MIGRATION, EXTRAVASATION OF CONTRAST, OR DEFORMATION. FILTER LEGS DID/DID NOT APPEAR OUTSIDE THE COLUMN OF CONTRAST AFTER FILTER PLACEMENT. THE ANGLE OF FILTER TILT IN THE AP VIEW WAS 4.3 DEGREES. THE 12 MONTH FOLLOW UP CT REVEALED A GRADE 3 FILTER LEG INTERACTION WITH THE IVC WALL. NO TREATMENT WAS PERFORMED. THE PATIENT REMAINS IN THE CLINICAL STUDY, AND NO OTHER DEVICE RELATED ADVERSE EVENTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582227 GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A 10827002330174

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other