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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 Malposition of Device (2616); Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problem Pain (1994)
Event Date 04/24/2017
Event Type  Injury  
Manufacturer Narrative

Manufacturing review: a lot history review was performed. This is the only complaint to date for this lot number. Therefore, a device history record review is not required. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Approximately eight years post filter deployment, a computed tomography revealed the apex of the filter touching and perhaps embedded into the anterior wall of the inferior vena cava. The filter was angled relative to the cephalad caudad direction of the inferior vena cava, the apex of the filter was pointed to the right upper quadrant. The apex of the filter was approximately at the level of the right renal vein, but below the level of left renal vein. The filter tip was at the level of mid inferior aspect of the l2 vertebral body. The filter struts are perforated through the vena cava wall. There was no clear fat plane between the vena cava and crossing transverse duodenum. Strut extension into the transverse duodenum cannot be excluded. One of the struts extended into the posterior medial margin of the aorta but not clearly into the aortic wall. Of the struts along the posterior medial margin of the aorta was fractured and bent. Therefore, the investigation is confirmed for the perforation of the ivc, filter limb detachment, material deformation and filter tilt. 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), (b)(4).

 
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 filter strut detached, perforated into aortic and small bowel, tilted and embedded in wall of the inferior vena cava. The device has not been removed and there were no reported attempts made to retrieve the filter. It was further reported that one of the struts along the aortic margin of filter detached and bent. The patient experienced abdominal and lower back pains. 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 Key10342772
MDR Text Key200961425
Report Number2020394-2020-05215
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 07/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF400J
Device LOT NumberGFSJ2518
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 07/30/2020 Patient Sequence Number: 1
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