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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - JUGULAR VENA CAVA FILTER Back to Search Results
Catalog Number RF320J
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pulmonary Embolism (1498)
Event Date 03/03/2011
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. This is the only event reported to date for this lot number and failure mode. Medical records review: the patient with bilateral pulmonary emboli and deep vein thrombosis (dvt) underwent vena cava filter placement and was discharged on instructions for six months of anticoagulation therapy. Approximately 16 months post filter placement, the patient presented to the emergency room for pain and swelling in the right leg and was noted to have discontinued anticoagulation therapy. Approximately four years post filter placement, the patient was diagnosed with pulmonary embolism with risk factors including morbid obesity, cellulitis, nicotine abuse and sedentary lifestyle. Doppler of the right lower extremity was positive for dvt and ct of the chest confirmed pe. The patient was given a thrombolytic and anticoagulation with instructions to continue with lifelong anticoagulation after discharge. Due to the patient¿s size, vascular intervention was not an option at that time. Approximately six years post filter placement, lower extremity duplex study was performed and confirmed presence of nonocclusive chronic dvt in the right lower extremity while on chronic anticoagulation. No reference to filter removal was found per the records available for review. No further information regarding the patient¿s current status was provided. Investigation summary: the device was not returned for evaluation and images were not provided for review. However, medical records were provided and reviewed. Approximately five years and four months post filter deployment, ct of the chest confirmed pe. Based on the provided medical records, it can be confirmed that the patient experienced pe after filter implantation. However, the origin and relationship has not been established in the provided medical records. Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter. Based upon the available information, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: potential complications: acute or recurrent pulmonary embolism. This has been reported despite filter usage. It is not known if thrombi passed through the filter, or originated from superior or collateral vessels. Procedures requiring percutaneous interventional techniques should not be attempted by physicians unfamiliar with the possible complications. Complications may occur at any time during or after the procedure. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed after being diagnosed with deep vein thrombosis/pulmonary embolism. Some time post filter deployment, the patient allegedly experienced recurrent pulmonary embolism. Patient status was not reported.
 
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Brand NameG2 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
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key7140795
MDR Text Key95588506
Report Number2020394-2017-01790
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052578
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Attorney
Type of Report Initial
Report Date 12/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2007
Device Catalogue NumberRF320J
Device Lot NumberGFQD3730
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/29/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/16/2006
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: 12/21/2017 Patient Sequence Number: 1
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