BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTION ELITE RETRIEVABLE VENA CAVA FILTER

    MDR report key: 4878555 · Received June 26, 2015

    Report

    Report Number
    3003862657-2015-00004
    Event Type
    Other
    Date Received
    June 26, 2015
    Date of Event
    March 27, 2014
    Report Date
    May 8, 2015
    Manufacturer
    REX MEDICAL, L.P.
    Product Code
    DTK
    PMA / PMN Number
    K081410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT F/U: EXAMINATION OF RETURNED PRODUCT (ONCE IT ARRIVES); REVIEW OF TREND ANALYSIS; REQUEST FOR CASE IMAGES, FILMS, VIDEOS, ETC. COMPLAINT SAMPLE EVALUATION: COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION AS OF THIS REPORT FILING. RETAIN DEVICE EVALUATION: NO DEVICE RETAIN EVALUATION WAS PERFORMED. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THIS PRODUCT COMPLAINT WAS DETERMINED TO BE TILTING OF THE FILTER AND SUBSEQUENT OVERGROWTH OF THE FILTER APEX LEADING TO THE DIFFICULT RETRIEVAL AND ULTIMATELY, THE FRACTURE OF THE FILTER LEG DURING RETRIEVAL. THIS PRODUCT COMPLAINT IS CONSIDERED AN ISOLATED INCIDENT. THIS INVESTIGATION WILL REMAIN OPEN PENDING ARRIVAL OF THE COMPLAINT PRODUCT FOR EVALUATION. REX MEDICAL WILL CONTINUE TO MONITOR 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: THE DOCTOR NEEDED TO USED ADVANCED FILTER RETRIEVAL TECHNIQUES BECAUSE THE FILTER HAD TILTED AND THE APEX OF THE FILTER WAS EMBEDDED TO THE IVC WALL. AFTER 7 TOTAL HOURS OF TRYING TO RETRIEVE THE FILTER THE DOCTOR WENT FEMORAL WITH ANOTHER SHEATH TO TRY AND ASSIST WITH THE FILTER REMOVAL AND ONCE IT WAS APEX WAS REMOVED FROM THE IVC WALL. THE FILTER WAS SNARED BY THE BODY AND WHILE IT WAS BEING PULLED UP INTO THE SHEATH ONE OF THE FILTER LEGS BROKE OFF. THE FILTER LEG WAS RETRIEVED AND NO HARM WAS DONE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416008 OPTION ELITE RETRIEVABLE VENA CAVA FILTER VENA CAVA FILTER DTK REX MEDICAL, L.P. 352506070E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other