BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMON NITINOL FILTER

    MDR report key: 6085098 · Received November 6, 2016

    Report

    Report Number
    MW5065853
    Event Type
    Injury
    Date Received
    November 6, 2016
    Date of Event
    October 15, 1999
    Report Date
    November 6, 2016
    Manufacturer
    BARD PERIPHERAL VASCULAR INC.
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS READMITTED TO (B)(6) HOSPITAL AFTER IT WAS DETERMINED THAT A DVT HAD PREVIOUSLY BEEN IN HOSPITAL FOR, HAD BEGUN TO MIGRATE. IN THE DAWN HOURS OF (B)(6) 1999 A SURGEON WHO HAD COME FROM (B)(6) TO (B)(6) INFORMED ME THAT SHE DID NOT CARE FOR THE GREENFIELD IVC FILTER USED THERE, SO SHE HAD BROUGHT ONE WITH HER TO PLACE IN MY INFERIOR VENA CAVA. AFTER THE SURGERY, MY DOCTOR TRIED NUMEROUS TIMES TO REMOVE ME FROM WARFARIN BUT THE FILLER IMMEDIATELY OCCLUDED AND I HAD TO BE REHOSPITALIZED AND PLACED ON IV HEPARIN AND THE DOSAGE OF THE WARFARIN INCREASED. I BEGAN CLOTTING IN MY LEFT LEG WORSE AND I WOULD BE IN HOSPITAL FOR WEEKS, DISCHARGED, AND BACK IN WITHIN HOURS OR DAYS WITH NEW CLOTS. I SAW SPECIALISTS WHO INFORMED ME THAT WITH THE BARD IVC FILTER BEING IN FOR MORE THAN A FEW WEEKS, IT COULD NOT BE REMOVED AND THE FILTER WAS WHY I WOULD HAVE TO REMAIN ON ANTICOAGULANTS FOR THE REST OF MY LIFE AND WOULD MOST LIKELY HAVE PROBLEMS WITH FUTURE CLOTS. I HAD TWO SEPARATE EPISODES OF DVT'S BREAKING OFF AND PASSING THROUGH THE FILTER AND I AM LUCKY TO BE ALIVE. MY LIFE HAS BEEN A CONSTANT NIGHTMARE OF HAVING TO CHECK MY INR'S WEEKLY AND USING PAINFUL FRAGMIN INJECTIONS WHEN MY LEVELS GO BELOW 2.7 FOR FOURTEEN DAYS TWICE A DAY. IF THE CLOT HAD BEEN TREATED PROPERLY IN THE FIRST PLACE, I WOULD NOT HAVE TO SPEND MY LIFE TRYING TO KEEP THE IVC FILTER FROM OCCLUDING. I AM NOW EXPERIENCING SEVERE ANEMIA AND CHEST PAINS, I HAVE HAD TO HAVE 2 PINTS OF WHOLE BLOOD AND MY DOCTORS ARE PUTTING ME THROUGH A LOT OF TESTS IN ORDER TO FIND THE ORIGIN OF MY CURRENT SYMPTOMS. MY VAN WAS HIT ON (B)(6) OF THIS YEAR AND IT WAS AFTER THIS THAT ALL OF THE NEW SYMPTOMS STARTED AND I FEAR THAT THE FILTER MAY BE AT THE ROOT OF THE SYMPTOMS. I KNOW THAT OVER THE YEARS THROUGH MANY SCANS AND X-RAYS THAT THE POSITION OF THE FILTER HAD CHANGED. I HAVE HAD MAJOR INFECTIONS AND DVT'S, PE'S AND IN ALL I SPENT ALMOST A YEAR GOING IN AND OUT OF (B)(6) AND HOME MONITORING AND FRAGMIN ARE THE MAIN REASONS I HAVE BEEN ABLE TO REMAIN OUT OF THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731973 SIMON NITINOL FILTER SIMON NITINOL FILTER DTK BARD PERIPHERAL VASCULAR INC. 2120F 990336

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| O| R| S ARTHRITIS STRENGTH TYLENOL| CARAFATE| COAGU CHECK | COAGU LANCETS| COAGU TESTING STRIPS| CRANBERRY TABLETS| DANTROLENE| FIBERCON| FISH OILS| FRAGMINE INJECTIONS SUB Q| GABAPENTIN| LEVOTHYROXINE| MULTI VITAMIN WITHOUT VITAMIN K| NIFEDIPINE| NITROFURANTOIN| OPANA ER| OTC MEDS: CALCIUM TABLETS| OXYMORPHONE (OPANA)| RX MEDS: DYAZIDE| SPIRONOLACTONE| TIZANIDINE| VITAMIN D3 50,000IU| WARFARIN| ZANTAC