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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. G2 X FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number RF400F
Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problem Abdominal Pain (1685)
Event Date 03/20/2019
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. The medical records included images. The image review was documented in the medical records. Medical records were provided and reviewed. Approximately nine years and four months of post deployment, computed tomography of abdomen was performed which showed that the filter apex was located 1 cm caudal to the right renal vein and was within the inferior vena cava, slightly superior to the inferior vena cava bifurcation. The filter was tilted with the apex adjacent to the right lateral wall of the inferior vena cava. There was a penetrating strut projected anteriorly into the mesenteric adipose extended 0. 5 cm anterior to the inferior vena cava wall. There was a strut projected posteriorly which remained within the lumen of the inferior vena cava. There was a strut projected anteriorly and medially which penetrated 0. 5 cm beyond the inferior vena cava lumen and was directly contiguous with the serosa of the aorta. The sixth strut projected posteriorly and medially and remained within the inferior vena cava lumen. Therefore, the investigation is confirmed for perforation of inferior vena cava (ivc) and filter tilt. 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: 09/2012.
 
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 filter tilted, struts perforated and the patient reportedly experienced abdominal pain. The device has not been removed and there were no reported attempts made to retrieve the filter. However, the current status of the patient is unknown.
 
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Brand NameG2 X 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 Key12201514
MDR Text Key262609153
Report Number2020394-2021-80664
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082305
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 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF400F
Device Lot NumberGFTG2563
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/02/2009
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: 07/21/2021 Patient Sequence Number: 1
Treatment
ALPRAZOLAM, KEFLEX, CYANOCOBALAMIN; FLONASE, LASIX, SYNTHROID, LYSINE; PRILOSEC, THERAGRAN, PREVACID AND VALTREX
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