BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTION ELITE RETRIEVABLE VENA CAVA FILTER

    MDR report key: 4649688 · Received March 3, 2015

    Report

    Report Number
    3003862657-2015-00001
    Event Type
    Other
    Date Received
    March 3, 2015
    Date of Event
    November 17, 2014
    Report Date
    February 20, 2015
    Manufacturer
    REX MEDICAL LP
    Product Code
    DTK
    PMA / PMN Number
    K081410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT FOLLOW UP: EXAMINATION OF RETURNED PRODUCT; REVIEW OF ALL MANUFACTURING RECORDS; REVIEW OF TREND ANALYSIS; REQUEST FOR CASE IMAGES, FILMS, VIDEOS, ETC. COMPLAINT SAMPLE EVALUATION: COMPLAINT SAMPLE WAS RETURNED TO FOR EVALUATION. RETAIN DEVICE EVALUATION: NO DEVICE RETAIN EVALUATION WAS PERFORMED. ROOT CAUSE: A DEFINITIVE ROOT CAUSE WAS DETERMINED TO BE PHYSICIAN ERROR WHEN EXAMINING THE CASE FILMS. THE REPORTED POSSIBLE FILTER PENETRATION WAS IN FACT CAVAL TENTING WHICH OCCURS WHEN A FILTER IS PLACED IN THE VENA CAVA. CASE IMAGES OF THE FILTER WITHIN THE PATIENT WERE PROVIDED FOR REVIEW BUT AFTER EVALUATING THE IMAGES, IT WAS DETERMINED THAT THERE WAS NO EVIDENCE OF CAVAL PENETRATION - THE IMAGES PROVIDED SHOW NORMAL TENTING OF A VENA CAVA POST FILTER PLACEMENT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE COMPLAINT PRODUCT LOT NUMBER IN QUESTION AND YIELDED NO ABNORMALITIES DURING MANUFACTURING AND KITTING. A REVIEW OF THE TREND ANALYSIS FOUND NO PREVIOUS INSTANCES OF A SIMILAR NATURE FOR THE OPTION ELITE VENA CAVA FILTER. THIS COMPLAINT IS CONSIDERED AN ISOLATED INCIDENT AND REX MEDICAL WILL CONTINUE TO MONITOR ALL FUTURE COMPLAINTS FOR INSTANCES OF THIS NATURE.

    Description of Event or Problem · 1

    AS REPORTED TO REX MEDICAL VIA (B)(4) PRODUCT EXPERIENCE REPORT FORM: PER THE RT, (B)(6) YEAR OLD GIRL HAD PRIOR HISTORY OF P.E. WAS GOING TO HAVE SURGERY, SO (PHYSICIAN) PLACED FILTER PROPHYLACTICALLY. AFTER ONE HOUR, SENT HER HOME TO HAVE HER COMPLAINT OF SIGNIFICANT PAIN IN HER BACK, ETC. SHE WAS RE-ADMITTED AND KEPT OVERNIGHT. CT SCAN LOOKED TO SHOW LEGS OF THE FILTER HAD PERFORATED THE CAVAL WALL. FILTER WAS REMOVED A COUPLE OF DAYS LATER. PATIENT IS BEING OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145969 OPTION ELITE RETRIEVABLE VENA CAVA FILTER VENA CAVA FILTER DTK REX MEDICAL LP 352506070E Q623503

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other