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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); Malposition of Device (2616); Detachment of Device or Device Component (2907)
Patient Problem Pain (1994)
Event Date 04/24/2014
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. Post filter deployment, patient presented with history of severe malposition¿s of the filter with chronic back pain and the filter was embedded into spine with an osteolytic reaction of approximately 8 mm. Subsequently filter retrieval was scheduled on the same day. An inferior venacavogram revealed, the filter appeared to be partially extruded through the vein wall. It was noted that one of the filter limbs has detached from the filter. Subsequent inferior venacavogram revealed with a different angulation, it was clearly seen that there was a significant extrusion of the top cap of the filter. The procedure was aborted after an unsuccessful attempt. Ten days later, patient was heparinized and presented for removal of filter. Small venotomy was performed at the area of the top cap and completely allowed it to extrude so that the hook became accessible. Then hook has been snared with a glide wire and placed a 10 french sheath over the wire as the noose on the snare with that it was able to collapse and retrieve the filter through a very small cavotomy that was repaired with a single 4-0 prolene suture. Therefore, the investigation is confirmed for the perforation of the ivc, malposition of the ivc filter, filter limb detachment and 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: 02/2013), (b)(4).

 
Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient with multiple sclerosis. At some time post filter deployment, it was alleged that the filter malpositioned, perforated, strut detached, difficult to remove and the patient reportedly experienced back pain. The device has been removed after unsuccessful percutaneous removal attempt. 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 Key10353967
MDR Text Key201345760
Report Number2020394-2020-05212
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK082305
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 07/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/01/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF400F
Device LOT NumberGFUA2475
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/15/2010
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: 08/01/2020 Patient Sequence Number: 1
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