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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 Patient Device Interaction Problem (4001)
Patient Problem Pulmonary Embolism (1498)
Event Date 06/10/2009
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. The patient presented to the emergency room approximately two months of post deployment after experiencing chest pain and increased shortness of breath. A computerized tomography scan of the patient¿s chest for pulmonary embolism at that time revealed increase in the clot burden compared to the previous exam and with new defects for the more recent study. The patient also had lower extremity dopplers two months as well as one month ago both being negative for evidence of thrombus. The next day, repeat pe computerized tomography showed increasing emboli with right heart strain which was unchanged from prior study. Already has an inferior vena cava filter. There were increasing filling defects and superior and inferior lingular arteries of the left upper lobe. Defects were also in the segmental artery supplying the anterior segment of the right upper lobe which was new. There was also new filling defect in the segmental artery to the posterior segment of the right upper lobe as well as a sub segmental branch and apical segment right upper lobe. New embolic defects were present in both medial lateral segmental arteries to the right middle lobe. Additional defects were present in the trunk vessels upon the basilar segments of the right lower lobe which extends into the segmental arteries supplying the medial and anterior basilar segmental arteries. Small defect was present in the segmental artery the posterior basilar segment of the right lower lobe. Around six months later, on assessment stated that evidence of chronic residual emboli in the right upper lobe anterior segment, right lower lobe posterior basal segment and left lower lobe posterior basal segment. No evidence of acute pulmonary embolism. Around nine years and five months later, computerized tomography-abdomen without contrast was performed which showed that an inferior vena cava filter appeared intact. The legs extending beyond the confines of the inferior vena cava as they did on the study eight years ago. Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc). Additionally, it can be confirmed that the patient experienced pe 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: 07/2010).
 
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 struts perforated the inferior vena cava wall. 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 Key12133973
MDR Text Key260455420
Report Number2020394-2021-80546
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
Type of Report Initial
Report Date 07/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF310F
Device Lot NumberGFRF3663
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/09/2007
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: 07/08/2021 Patient Sequence Number: 1
Treatment
ACETAMINOPHEN-OXYCODONE, NYSTATIN, TOPIRAMATE; DICYCLOMINE, RIVAROXABAN, PREGABALIN; ENOXAPARIN, OXYCODONE, WARFARIN; EPINEPHRINE, MORPHINE, ESOMEPRAZOLE; IBUPROFEN, DILAUDID; ONDANSETRON, DOCUSATE, SIMETHICONE; TYLENOL, DILTIAZEM, AMITRIPTYLINE, TRAMADOL
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