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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 Difficult to Remove (1528); Obstruction of Flow (2423); Malposition of Device (2616); Extrusion (2934); Patient Device Interaction Problem (4001)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
A manufacturing review was performed. The lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only complaint reported to date for this lot number and failure mode. The device was not returned for evaluation and images were not provided for review. However, medical records were provided and reviewed. Approximately three years post filter deployment, a ct scan reported ¿rightward tilt of the filter with several legs having penetrated the ivc wall. One filter leg may be within the aortic wall¿. Approximately five years post filter deployment, during a retrieval attempt, neither wire or catheter could pass below the ivc filter, however, glidewire was passed down through the filter. With resistance at the top of the filter, cavography showed caval occlusion at that level, segmental caval occlusion with large draining collateral veins and left iliac system filled retrograde. There was no noted attempt at filter retrieval. Therefore, based on the provided medical records, the investigation is confirmed for a tilted filter and perforation of the ivc. The investigation is unconfirmed for retrieval difficulties as no retrieval attempt was made. Based upon the available information, the definitive root cause is unknown. Labeling review:the current ifu (instructions for use) states: warnings: movement, migration or tilt of the filter are known complications of vena cava filters. Note: it is possible that complications such as those described in the "warnings", "precautions," or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted. Potential complications: movement, migration or tilt of the filter are known complications of vena cava filters. Filter malposition. Filter tilt. Perforation or other acute or chronic damage if the ivc wall.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in conjunction with trauma/motor vehicle accident. Some time post filter deployment, the filter allegedly tilt and embedded in the wall of the ivc; the device has not been removed after an attempted but unsuccessful percutaneous removal procedure. The patient status is unknown at this time.
 
Manufacturer Narrative
No medical images have been made available to the manufacturer. Medical records were provided and reviewed. As the lot number for the device was provided, a review of the device history records is currently being performed. The device has not been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. Medical records review: the patient with deep vein thrombosis in the left lower extremity and pulmonary embolus underwent infrarenal vena cava filter placement via femoral access with no complications. Venacavogram confirmed good positioning and proper deployment. A ct scan performed three years later demonstrated rightward tilt of the filter with several legs having penetrated the inferior vena cava wall, one filter leg may be within the aortic wall. Approximately five years post filter placement, the patient presented for retrieval of the filter. The right internal jugular vein was accessed and a wire or catheter could not pass below the filter as resistance was met at the top of the filter. Cavography at this level showed caval occlusion. A glidwire was passed down through the filter and into the infrarenal vena cava and demonstrated segmental caval occlusion with large draining collateral veins, the infrarenal vena cava and left iliac system filled retrograde. At that point, the procedure was concluded and no attempts were made to retrieve the filter. The impression was chronic well collateralized occlusion of the ivc. No further information is noted regarding the patient¿s current status. 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 in conjunction with trauma/motor vehicle accident. Some time post filter deployment, the filter allegedly tilt and embedded in the wall of the ivc; the device has not been removed after an attempted but unsuccessful percutaneous removal procedure. The patient status is unknown at this time.
 
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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
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key7153019
MDR Text Key268705177
Report Number2020394-2017-01833
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,Followup,Followup,Followup,Followup
Report Date 08/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2012
Device Catalogue NumberRF400F
Device Lot NumberGFTC4657
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/27/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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