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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 Filter (816); Device Operates Differently Than Expected (2913); Extrusion (2934)
Patient Problems Abdominal Pain (1685); Perforation (2001); Great Vessel Perforation (2152)
Event Date 12/30/2008
Event Type  Injury  
Manufacturer Narrative

No device or medical images have been made available to the manufacturer. As the lot number for the device was not provided, a review of the device history records could not be performed. The investigation of the reported event is currently underway. Medical records were received and reviewed. Patient had a g2 express jugular filter deployed for history of dvt and pulmonary embolism. Approximately one month post filter deployment, a ct scan of the abdomen demonstrated several filter limbs perforating the ivc wall. The following month, the vena cava filter was captured and retrieved successfully; there was no reported patient injury. Upon successful removal of the vena cava filter, a new g2 express jugular filter was deployed inferior to the renal takeoffs in an upright position. A ct scan performed one year post filter deployment demonstrated the filter was in good position in the ivc. 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 that approximately one month post filter deployment, a ct scan demonstrated several filter limbs perforating the ivc wall. Three days post ct scan, a snare device was used to successfully capture and retrieve the filter without incident. Upon filter removal another vena cava filter was deployed inferior to the renal takeoffs for protection of dvt and pulmonary embolism. There was no reported patient injury.

 
Manufacturer Narrative

A manufacturing review could not be conducted as the lot number was not provided. Visual/microscopic inspection: as the device was not returned, an inspection could not be performed. Functional/performance evaluation: as the device was not returned, an evaluation could not be performed. Image/photo review: no images or photos have been made available to the manufacturer. Conclusion: the medical records allege that a ct scan demonstrated several filter limbs perforating the ivc wall. The filter was allegedly captured and retrieved successfully. Based on the medical records, the investigation is confirmed for perforation of the ivc. Based upon the available information, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: potential complications: perforation or other acute or chronic damage of the ivc wall.

 
Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed. Visual/microscopic inspection: as the device was not returned, an inspection could not be performed. Functional/performance evaluation: as the device was not returned, an evaluation could not be performed. Medical records review (first): the patient had a filter deployed for history of dvt and pulmonary embolism. Approximately one month post filter deployment a ct scan of the abdomen demonstrated several filter limbs perforating the ivc wall. Three days post ct scan, a filter retrieval procedure was performed for complaint of abdominal pain. The vena cava filter was captured and retrieved successfully with the use of a snare device. Upon successful removal of the vena cava filter a new vena cava filter was deployed inferior to the renal takeoffs in an upright position. A ct scan performed one year post filter deployment demonstrated the filter was in good position in the ivc. Medical record review (second): the patient was referred for an inferior vena cava filter deployment with history of multiple dvts, pulmonary embolus and coagulopathy. The patient was prepped and draped in normal sterile fashion. The right internal jugular vein was accessed and a venogram was performed. The filter was successfully deployed below the renal veins without difficulty. Hemostasis was achieved and the patient was transferred to his room in stable condition. Image/photo review: as medical images were not provided, a review could not be performed. Conclusion: neither the device nor images were returned. Medical records were provided. The medical records allege that a ct scan demonstrated several filter limbs perforating the ivc wall. The filter was allegedly captured and retrieved successfully. Based on the medical records, the investigation is confirmed for perforation of the ivc. Based upon the available information, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: potential complications: perforation or other acute or chronic damage of the ivc wall.

 
Event Description

It was reported that approximately one month post filter deployment, a ct scan demonstrated several filter limbs perforating the ivc wall. Three days post ct scan, a filter retrieval procedure was scheduled due to complaint of abdominal pain. A snare device was used to successfully capture and retrieve the filter without incident. Upon filter removal another vena cava filter was deployed inferior to the renal takeoffs for protection of dvt and pulmonary embolism. There was no reported patient injury. New information received: medical records were received and reviewed. The patient was referred to filter deployment with history of multiple dvts and pe. The filter was deployed without difficulty below the level of the renal veins. Hemostasis was achieved and the patient was transferred in stable condition. No additional information was provided in the medical records received.

 
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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
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key5196711
MDR Text Key30204894
Report Number2020394-2015-01789
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 COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/06/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/02/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF400J
Device LOT NumberUNKNOWN
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 Received07/08/2016
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: 11/02/2015 Patient Sequence Number: 1
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