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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR INC. SIMON NITINOL FILTER

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BARD PERIPHERAL VASCULAR INC. SIMON NITINOL FILTER Back to Search Results
Model Number 2120F
Device Problem Occlusion Within Device (1423)
Patient Problems Pulmonary Embolism (1498); Anemia (1706); Chest Pain (1776); Unspecified Infection (1930); Thrombosis (2100)
Event Date 10/15/1999
Event Type  Injury  
Event Description
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.
 
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Brand NameSIMON NITINOL FILTER
Type of DeviceSIMON NITINOL FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR INC.
1415 w 3rd st.
ste 109
tempe AZ 85280
MDR Report Key6085098
MDR Text Key59495300
Report NumberMW5065853
Device Sequence Number1
Product Code DTK
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2016
Is this an Adverse Event Report? Yes
Device Operator
Device Model Number2120F
Device Lot Number990336
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/06/2016 Patient Sequence Number: 1
Treatment
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
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