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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 Incompatibility (2682)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 04/24/2018
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 nine years and four months later, a computed tomography of abdomen and pelvis was performed for right sided lower groin pain. The study showed that the apex of the filter at 2. 1 cm below the left renal vein. No filter tilt and fracture were noted. There are multiple struts perforating the wall of the inferior vena cava. The struts perforating the wall of the duodenum and aorta. After six months, patient was planned for filter removal. Inferior vena cavogram showed filter was centered in the inferior vena cava with otherwise normal inferior vena cava, no clot visible in the filter on pre-removal imaging. The filter was intact with a focus of calcified thrombus at the apex, larger in diameter than the lumen of the cone sheath and accounting for the removal failure using that device. Through the right internal jugular vein approach, attempted to retrieve the filter using the bard recovery cone was failed. The cone readily captured the filter, but it could not be withdrawn into the sheath. This effort was abandoned. The filter was removed successfully using the endobronchial forceps in the jaws of life technique. Post removal cavogram showed normal study. The filter was inspected and found to be removed in its entirety. Therefore, the investigation is confirmed for the alleged perforation of the inferior vena cava. Additionally, it can be confirmed that the patient experienced thrombus above the filter 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: 11/2011).

 
Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient for high risk of pulmonary embolism. At some time post filter deployment, it was alleged that the filter struts perforated. The device was removed percutaneously. 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 Key12334996
MDR Text Key267023561
Report Number2020394-2021-80704
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK062887
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 08/18/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/18/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF310F
Device LOT NumberGFSJ2338
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/13/2008
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: 08/18/2021 Patient Sequence Number: 1
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