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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - JUGULAR VENA CAVA FILTER Back to Search Results
Catalog Number RF320J
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Chest Pain (1776)
Event Date 03/01/2021
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and 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. After post filter deployment, computed tomography (ct) revealed that single leg of the filter had broken off and embolized to the right lower lobe posterior basilar segment artery. Approximately two years and three months later, the patient presented for filter removal using real-time sonographic guidance. The g2 recovery retrievable filter removal cone system was placed through the sheath. Then the filter retrieval cone was placed over the apex of the filter. The retrieval cone was then compressed with the sheath, results in retraction of the filter legs. The filter was then removed in its entirety. The patient had dislodged filter, which was partially retrieved. Approximately eight months and twenty-one days later, computed tomography (ct) revealed that there was a thin linear hyper-density along the distal right lower lobe pulmonary artery branch without arterial thrombosis or pulmonary parenchymal abnormalities, that may represent radiopaque foreign body related to part of the filter. The patient reportedly experienced chest pain. Therefore, the investigation is confirmed for the alleged filter limb detachment. The definitive root cause could not be determined based upon available information. Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate. (expiry date: 11/2010).
 
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. At some time post filter deployment, it was alleged that the single leg of the filter had broken off. The device has been removed percutaneously. The patient reportedly experienced chest pain. However, the current status of the patient is unknown.
 
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Brand NameG2 FILTER SYSTEM - JUGULAR
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 12804
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key11567712
MDR Text Key242179734
Report Number2020394-2021-00683
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052578
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 03/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF320J
Device Lot NumberGFRJ3559
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/19/2007
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: 03/25/2021 Patient Sequence Number: 1
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