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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 Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001); Migration (4003)
Patient Problems Chest Pain (1776); Cardiac Perforation (2513); Foreign Body In Patient (2687)
Event Date 02/10/2017
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. Bard g2 filter was deployed with its tip at the level immediately below the renal veins for a patient with deep vein thrombosis. Post placement venogram was performed and demonstrated no complications and excellent positioning of the filter. Approximately nine years and six months of post deployment, a computed tomography of abdomen and pelvis was performed for right groin and flank pain. The study showed that inferior vena cava filter was noted at the level of right renal vein. The four most medial tines of the filter project beyond the caval margin. One month later, patient presented for filter removal. Through the right internal jugular vein approach, an inferior vena cavogram was performed, demonstrated a patent cava with brisk drainage and no filling defects to suggest thrombus. The vena cava was normal in caliber without anomalies. The inferior vena cava filter was missing a tine and many of the tines are perforating vena cava. Numerous spot images were obtained of the chest to document the known embolized tine and that was noted within the right ventricular wall. Through the right internal jugular vein access, a sheath was inserted, and filter hook ensnared with a loop snare. The filter was then collapsed and retracted through the sheath. Post retrievable inferior vena cavogram was performed, which demonstrated a patent cava with brisk drainage and no evidence of caval injury or filling defects to suggest thrombus. Therefore, the investigation is confirmed for filter migration, perforation of inferior vena cava (ivc), filter limb detachment. However, the investigation is inconclusive for retrieval difficulties. 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: 05/2010).

 
Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident. At some time post filter deployment, it was alleged that the filter migrated to heart, struts detached, and perforated. The device has not been removed after an attempted but unsuccessful percutaneous removal procedure. The detached strut retained in right ventricle. 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 Key12127761
MDR Text Key260242138
Report Number2020394-2021-80544
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 07/07/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/07/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF310F
Device LOT NumberGFRE0612
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/23/2007
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: 07/07/2021 Patient Sequence Number: 1
Treatment
CEPHALEXIN AND NORTRIPTYLINE; IBUPROFEN AND OMEPRAZOLE
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