BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTION RETRIEVABLE VENA CAVA FILTER

    MDR report key: 2214253 · Received July 26, 2011

    Report

    Report Number
    3003862657-2011-00002
    Event Type
    Other
    Date Received
    July 26, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 22, 2011
    Manufacturer
    REX MEDICAL L.P.
    Product Code
    DTK
    PMA / PMN Number
    K081410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT FOLLOW UP: SEVERAL ATTEMPTS TO REACH THE PHYSICIAN WHO INITIALLY PLACED THE OPTION FILTER WERE UNSUCCESSFUL (LEFT MESSAGES TWICE ON (B)(6) 2011 AND ONCE ON (B)(6) 2011). COMPLAINT SAMPLE EVAL: THE COMPLAINT SAMPLE WAS NOT RETURNED TO REX FOR EXAMINATION BY THE ENGINEERING TEAM. RETAIN DEVICE EVAL: THERE WERE NO RETAIN DEVICE EVALUATIONS AS THE LOT NUMBER OF THE COMPLAINT SAMPLE WAS NOT PROVIDED. ROOT CAUSE: A DEFINITIVE ROOT CAUSE WAS DETERMINED TO BE A USER ERROR DURING INITIAL PLACEMENT OF THE FILTER IN THE PT. AS STATED BY THE REPORTING PHYSICIAN: "I HAVE SEEN THE INITIAL PLACEMENT FILMS AND IT WAS PLACED AT THE ILIAC CONFLUENCE, FAR LOWER THAN THE NORMAL POSITION JUST BELOW THE RENAL VEINS. AT THAT TIME, ONE OF THE LEGS EXTENDED TO THE LEFT INTO THE LEFT COMMON ILIAC VEIN. APPARENTLY, NO ATTEMPT WAS MADE AT THAT TIME TO REPOSITION THE FILTER." THE INITIAL PLACEMENT OF THE FILTER LED TO THE DIFFICULT RETRIEVAL BY THE REPORTING PHYSICIAN. A PROPERLY PLACED FILTER WOULD NOT HAVE ALLOWED FOR A FILTER LEG TO ENTER ONE OF THE ILIAC VEINS AS DESCRIBED.

    Description of Event or Problem · 1

    AS REPORTED BY DR (B)(6) VIA EMAIL ON (B)(6) 2011: "THE FILTER WAS PLACED AT (B)(6) ON (B)(6) 2011, BY ONE OF THE IR MDS, (B)(6) OR SOMETHING LIKE THAT. I WOULD OF COURSE NOT HAVE THE LOT NUMBER, PERHAPS YOU CAN FOLLOW UP WITH (B)(6) AND GET THAT. THERE WAS A FAILED ATTEMPT BY A DR (B)(6), AN IR MD AT (B)(6), ON (B)(6) 2011, FROM JUGULAR AND TRANSFEMORAL APPROACH. GIVEN THIS INFO, THEY SHOULD BE ABLE TO FIGURE OUT THE NAME, AS I CANNOT PROVIDE IT TO YOU FOR HIPAA REASONS. I CANNOT SAY FOR SURE WHY THE FILTER TILTED IN FIRST PLACE; I HAVE SEEN THE INITIAL PLACEMENT FILMS AND IT WAS PLACED AT THE ILIAC CONFLUENCE, FAR LOWER THAN THE NORMAL POSITION JUST BELOW THE RENAL VEINS. AT THAT TIME, ONE OF THE LEGS EXTENDED TO THE LEFT INTO THE LEFT COMMON ILIAC VEIN. APPARENTLY, NO ATTEMPT WAS MADE AT THAT TIME TO REPOSITION THE FILTER. THE TIP OF THE FILTER SUBSEQUENTLY BECAME DEEPLY WALL EMBEDDED AND THERE IS GRADE 1-2 PENETRATION OF SEVERAL OF THE LEGS OF THE FILTER. I WAS ABLE TO REMOVE THE FILTER YESTERDAY USING OUR JAWS OF LIFE TECHNIQUE (ENDOBRONCHIAL FORCEPS) AND THE PT IS DOING WELL AT THIS POINT; I WILL BE REPEATING A CT VENOGRAM IN (B)(6)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTION RETRIEVABLE VENA CAVA FILTER VENA CAVA FILTER DTK REX MEDICAL L.P. 352506070 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention