BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTION RETRIEVABLE VENA CAVA FILTER

    MDR report key: 3122641 · Received May 17, 2013

    Report

    Report Number
    3003862657-2013-00003
    Event Type
    Other
    Date Received
    May 17, 2013
    Date of Event
    April 16, 2013
    Report Date
    May 17, 2013
    Manufacturer
    REX MEDICAL, L.P.
    Product Code
    DTK
    PMA / PMN Number
    K081410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT F/U: REVIEW OF CASE SUMMARY WITH PHYSICIAN; SAMPLE RETURNED FOR EVAL; CASE IMAGES, VIDEOS, ETC. WERE PROVIDED FOR REVIEW. COMPLAINT SAMPLE EVAL: COMPLAINT SAMPLE WAS RETURNED TO REX FOR REVIEW ON (B)(4) 2013. RETAIN DEVICE EVAL: NO DEVICE RETAIN EVAL PERFORMED FOR THIS LOT NUMBER. ROOT CAUSE: A PRELIMINARY DEFINITIVE ROOT CAUSE FOR THIS PRODUCT COMPLAINT IS THE INITIAL LOCATION AT WHICH THE FILTER WAS PLACED WITHIN THE VENA CAVA. THE FILTER WAS PLACED WITHIN A BEND IN THE VENA CAVA WHICH PUT UNDUE STRESSES ON ONE SIDE OF THE FILTER; THE SIDE WHICH ULTIMATELY FRACTURED. CONCLUSION: THE INITIAL PLACEMENT LOCATION WAS POOR AS THE FILTER COULD HAVE BEEN PLACED MORE PROXIMAL THEREBY AVOIDING THE CURVATURE WITHIN THE CAVA AND THE UNDUE STRESSES PLACED UPON THE FILTER LEADING TO THE EVENTUAL FRACTURE. THIS COMPLAINT REMAINS OPEN AS REX IS AWAITING POST-PLACEMENT IMAGES TO VERIFY INITIAL LOCATION OF THE FILTER. THIS COMPLAINT IS CONSIDERED AN ISOLATED INCIDENT AS THIS IS THE FIRST REPORT OF AN OPTION FILTER THAT WAS FOUND TO BE FRACTURED PRIOR TO RETRIEVAL FROM A PT. REX MEDICAL WILL CONTINUE TO MONITOR ALL FUTURE PRODUCT COMPLAINTS FOR INSTANCES OF THIS NATURE.

    Description of Event or Problem · 1

    AS REPORTED TO REX MEDICAL VIA ARGON MEDICAL DEVICES PRODUCT EXPERIENCE REPORT FORM: OPTION INITIALLY PLACED W/O SIGNIFICANT TILT ON (B)(6) 2013 BY (PHYSICIAN). LEG FRACTURES WAS PRESENT PRIOR TO FILTER RETRIEVAL. FILTER WAS RETRIEVED, BUT FRACTURED LEG WAS LEFT IN PT BECAUSE IT PERFORATED PERITONEUM. FILTER WAS GIVEN TO REP BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219220 OPTION RETRIEVABLE VENA CAVA FILTER VENA CAVA FILTER DTK REX MEDICAL, L.P. 352506070 S39896

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention