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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - FEMORAL VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number RF310F
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pulmonary Embolism (1498)
Event Date 01/16/2009
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: a device history record review could not be performed as the lot number is unknown. Investigation summary: the device was not returned for evaluation. The medical records included images. The image review was documented in the medical records. Medical records were provided and reviewed. After ten days of post filter deployment, upper extremity venous duplex unilateral indicated acute deep vein thrombosis without compressibility was seen at the level of the right brachial vein. Conclusions: positive for deep vein thrombosis in the right upper extremity. Lung ventilation¿perfusion scan indicated normal distribution of the radioisotope on the ventilatory as well as perfusion phase. No mismatched defects are seen to suggest pulmonary embolus. Impression given: low probability of pulmonary embolus. After five years and eleven months, computed tomography of abdomen and pelvis with and without contrast was performed which showed there was an inferior vena cava filter in place. Below the level of the inferior vena cava filter, the inferior vena cava appears to be small and there are multiple collateral vessels. Findings raise suspicion for chronic occlusion of the inferior vena cava. After eight months, computed tomography of abdomen and pelvis with contrast was performed which showed inferior vena cava filter in proper position and orientation. The inferior vena cava caudal to the filter was small and likely chronically thrombosed and collateralized. After one year and eight months, the patient experienced back pain, computed tomography scan of lumbar spine was performed which showed inferior vena cava filter in proper position and orientation. After three months, patient referred for evaluation of fractured inferior vena cava filter, which was placed in previously. Patient states that he has been experiencing pain on left side and center of chest onset for 4 months and seems to be worsening. Physician discussed and proposed that the filter did not cause symptoms. Also specified that risks outweigh benefits of filter removal 7 years later especially high risk even for open procedure with anticoagulation, liver transplant and possibly occluded cava with collateral veins. After three months, computed tomography of abdomen and pelvis with contrast was performed for post inferior vena cava filter status which showed supernumerary vessels throughout the anterior abdominal wall are consistent with venous collaterals suspect from infra-filter inferior vena cava obstruction. After seven months, computed tomography angiography of abdomen with and without contrast was performed which revealed an inferior vena cava filter, unremarkable in position. Above the filter, the inferior vena cava appears patent and normal caliber, through the intrahepatic portion and into the right atrium. Below the filter, the inferior vena cava caliber was normal whereas it appeared collapsed on the prior study when it was suspected to be thrombosed. There was no contrast seen in the inferior vena cava below the filter, but this was not necessarily as it was typical on computed tomography angiography (not venography), filling of the inferior vena cava was seen when contrast circulates through kidneys and then flows cephalad. After one month, evaluation for possible inferior vena cava filter removal. Patient has had a liver transplant above filter placement. It looks like filter had clot within it and patient developed large collaterals on his abdominal wall for venous status. Physician proposed that discussion was made, and it was not a clear indication for removal and probably filter saved patient life. Patient was inquisitive about the type of filter. However, physician concurred with multiple other expert physicians that the filter should be left in situ. Plan indicated that it looks like filter has thrombus within it and contraindicated for removal. There were no device deficiencies identified within the medical records. Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter. Additionally, it can be confirmed that the patient experienced pulmonary embolism post deployment. However, the relationship to the filter is unknown. Based on the available information, the definitive root cause is unknown. Labeling review: a review of product labeling documents (e. G. Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with right hip fracture, preventative. At some time, post filter deployment, it was alleged that the patient was diagnosed with low probability of pulmonary embolism. The device has not been removed and there were no reported attempts made to retrieve the filter. The current status of the patient is unknown.
 
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Brand NameG2 FILTER SYSTEM - FEMORAL
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key12818516
MDR Text Key280806957
Report Number2020394-2021-80808
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062887
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF310F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received10/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/16/2021 Patient Sequence Number: 1
Treatment
COUMADIN, LASIX, KCI, HEMOCYTE, LEXAPRO; CYPIONATE, ZOFRAN, PROAIR HFA, KETOCONAZOLE; GABAPENTIN, LEVATOL, DOVONEX, OMEPRAZOLE; LASIX, BACTRIM, SEROQUEL, DILAUDID, LISINOPRIL; METOPROLOL TARTRATE, XANAX, TESTOSTERONE; OXY IR 5, VALIUM, ARIXTRA, HYDROMORPHONE; PROGRAF, DOXYCYCLINE, SOMA, OXY-CR; ROBAXIN, NEURONTIN, LAMICTAL
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