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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. G2 EXPRESS FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number RF400F
Device Problems Obstruction of Flow (2423); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001); Migration (4003)
Patient Problems Pulmonary Embolism (1498); Cardiac Tamponade (2226); Cardiac Perforation (2513)
Event Date 01/04/2009
Event Type  Injury  
Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Approximately two weeks later, the patient underwent right and left heart catheterization. A cook needle was used to easily access the right common femoral vein with an anterior wall puncture. Under fluoroscopy, a balloon-tipped catheter was advanced into the inferior vena cava. The balloon was kept deflated as it was slowly advanced up the inferior vena cava. There was a recently placed inferior vena cava filter. The catheter was slowly advanced across the filter without disruption of the filter position. It passed very easily with no resistance. Within the right atrium, the balloon tip was inflated. Pressures were monitored and at this point, the balloon was deflated, the catheter was withdrawn slowly across the heart and into the inferior vena cava. It was slowly bought down across the inferior vena cava filter without any resistance and without disruption of the position or confirmation of the filter. The balloon tipped catheter was removed completely. After two days, a computed tomography angiography (cta) chest with intravenous contrast showed that there were extensive filling defects within both the upper and lower lobe left and right segmental pulmonary arteries. Filling defect was also seen in the distal left and right main pulmonary arteries. These findings were consistent with bilateral pulmonary emboli. Irregularity and eccentric location of emboli suggested an acute on chronic component. After five months, a computed tomography (ct) skull base-mid thigh showed that an inferior vena cava filter was present below the level of the renal veins. After six months, a computed tomography angiography (cta) showed pulmonary emboli. On an unknown date, the patient presented with cardiac tamponade. After two years and seven months, a computed tomography (ct) chest without intravenous contrast demonstrated that a filter was still noted in the inferior vena cava. After four months, the patient presented with right-sided abdominal pain, recurrent pulmonary embolism and diagnosed with status post inferior vena cava filter twice before. On the same day, a computed tomography (ct) abdomen and pelvis with intravenous contrast showed that an inferior vena cava filter was in place. Therefore, the investigation is confirmed for the alleged filter occlusion. However, the investigation is inconclusive for the alleged filter detachment, perforation of the inferior vena cava, filter migration. 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. (expiry date: 04/2011).

 
Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism. At some time post filter deployment, it was alleged that the filter clogged, migrated,struts perforated and detached. The device has not been removed and there were no reported attempts made to retrieve the filter. It was further reported that the detached struts retained in right ventricle with penetration into septum and another leg in the pericardial space overlying the lateral left ventricle. Further more, filter fragments are in the left lobe liver and leg in the right pulmonary artery. The patient was diagnosed with pulmonary embolism post filter implant; however, the current status of the patient is unknown.

 
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Brand NameG2 EXPRESS 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 Key12187315
MDR Text Key262150479
Report Number2020394-2021-80574
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK080668
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 07/19/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/19/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF400F
Device LOT NumberGFSC1094
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/15/2008
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: 07/19/2021 Patient Sequence Number: 1
Treatment
COUMADIN, UPTRAVI, SINGULAIR AND MACITENTAN; PREDNISONE, BACTRIM, DIOVAN AND CELLCEPT; SYNTHROID, LASIX, PRILOSEC AND TRACLEER
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