BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTION RETRIEVABLE VENA CAVA FILTER SYSTEM

    MDR report key: 1550244 · Received December 2, 2009

    Report

    Report Number
    3003862657-2009-00001
    Event Type
    Other
    Date Received
    December 2, 2009
    Date of Event
    October 27, 2009
    Report Date
    December 1, 2009
    Manufacturer
    REX MEDICAL, L.P.
    Product Code
    DTK
    PMA / PMN Number
    K081410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED TO OBTAIN ANY AND ALL INFORMATION PERTAINING TO THE OPTION FILTER PLACEMENT. A REVIEW BY THE REX MEDICAL ENGINEERING TEAM, AS WELL AS, REX MANAGEMENT, OF THE FILTER PLACEMENT PHOTO TAKEN BY DR. (B)(4) SHOWS THAT THE OPTION FILTER APPEARS TO HAVE BEEN PLACED IMPROPERLY WITHIN THE PATIENT. IT APPEARS THAT THE FILTER WAS PLACED IN THE LUMBAR VEIN AND NOT THE IVC. PER LABELING REQUIREMENTS, THE OPTION FILTER IS TO BE PLACED IN THE IVC. FURTHERMORE, UPON EVALUATION OF THE SUBMITTED IMAGE, IT DOES NOT APPEAR THAT THE FILTER LEGS WERE ENTANGLED PER THE USER'S STATEMENT. A REQUEST FOR ADDITIONAL IMAGES COULD NOT BE COMPLETED, AS THIS WAS THE ONLY PHOTO/IMAGE TAKEN DURING THE PROCEDURE. WE DID GET CONFIRMATION FROM DR. (B)(4) THAT THE FILTER WAS PLACED FROM A JUGULAR APPROACH. MISPLACEMENT OF IVC FILTERS INTO THE LUMBAR VEIN IS MORE FREQUENT FROM A JUGULAR APPROACH THAN A FEMORAL APPROACH AND IS COMMONLY MISTAKEN FOR PLACEMENT IN THE IVC. THIS APPEARS TO BE A USER ERROR ISOLATED INCIDENT.

    Description of Event or Problem · 1

    PHYSICIAN CALLED AND SAID THE OPTION FILTER DID NOT OPEN UP AND WAS A RISK FOR MIGRATION. TO HIM, IT APPEARED THE LEGS GOT TANGLED AND WAS NOT ALLOWING IT TO OPEN ALL THE WAY. HE SAID THAT AFTER PLAYING WITH IT A LITTLE, HE FORCED ONE LEG TO OPEN, BUT THE OTHERS WOULD NOT. HE WAS UNABLE TO RETRIEVE THE FILTER DUE TO THE PATIENT'S MEDICAL CONDITION. THE PATIENT WAS IN ICU AND HE DEPLOYED THE FILTER BED SIDE USING A PORTABLE C ARM. HE SENT A PICTURE THAT WAS FORWARDED ON TO THE ANGIOTECH VASCULAR PRODUCT MANAGER VIA PHONE. HE WILL BE FORWARDING OTHER PICTURES AS SOON AS POSSIBLE, HE SAYS. ON (B)(6), THE PHYSICIAN CALLED THE ANGIOTECH SALES REPRESENTATIVE BACK AND SAID THAT THE PATIENT HAD DIED. HE SAID THE PATIENT HAD CLOTS THROUGHOUT HER BODY, AND SHE WAS DISCOVERED UNCONSCIOUS IN HER HOUSE AND WAS IN REALLY BAD SHAPE. HE DID NOT ATTRIBUTE THE DEATH TO THE FILTER BUT DID NOT KNOW THE CAUSE OF DEATH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death