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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. G2 EXPRESS FILTER SYSTEM - JUGULAR VENA CAVA FILTER Back to Search Results
Catalog Number RF400J
Device Problems Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Patient Problems Pulmonary Embolism (1498); Thrombus (2101); Palpitations (2467)
Event Date 02/14/2019
Event Type  Injury  
Manufacturer Narrative

Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Approximately eleven years post filter deployment, ct revealed filter approximately at the level of l1 and some of the wires struts extend through the ivc and extraluminal. Additionally, metallic wires which are likely two separate wires, less likely a single wire curved back on itself within the base of the heart likely in the right atrium. The maximum length is approximately 4cm. Approximately on month later, ct revealed fractured filter and an ivc filter strut penetrating the inferior wall of the right ventricle near the septal leaflet of the tricuspid valve and which extends 1. 5 cm into interventricular groove and sub epicardial fat. Another strut was in the right medial basal segmental pulmonary artery. Therefore, the investigation is confirmed for filter limb detachment and perforation of the ivc. However, the investigation is inconclusive for pe post implant. Based upon 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 struts detached and perforated into the organs. The device along with detached struts were removed percutaneously. It was further reported that the detached struts migrated to heart and lungs. The patient was diagnosed with pulmonary embolism post implant and experienced heart palpitations; however, the current status of the patient is unknown.

 
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Brand NameG2 EXPRESS 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 NY 12804
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key9768692
MDR Text Key181489455
Report Number2020394-2020-01136
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,Followup
Report Date 06/25/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/28/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF400J
Device LOT NumberGFSC1160
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2008
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: 02/28/2020 Patient Sequence Number: 1
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