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

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.

• Brand Name: G2 X FILTER SYSTEM - FEMORAL
• Type of Device: VENA 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 Key: 10353967
• MDR Text Key: 201345760
• Report Number: 2020394-2020-05212
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082305
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• 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 Received: 08/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF400F
• Device Lot Number: GFUA2475
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR