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

Catalog Number RF400F

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problems Chest Pain (1776); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 04/16/2019

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.Approximately ten years post filter deployment chest x-ray revealed there linear radiopaque foreign body measuring 2.9 cm in length projected upon the heart at the left base medially on the frontal radiograph and anteriorly on the lateral radiograph, therefore this may be within the right ventricle.This was likely a fragment from the patient's inferior vena cava filter which was embolized.The computed tomography (ct) revealed metallic foreign body in right ventricle likely represented fractured leg from inferior vena cava filter.The patient endorsed cough and pain along ribs.The transthoracic echocardiogram (tte) showed that a trace pericardial effusion appeared present and trace mitral regurgitation.There were no echocardiographic indications of cardiac tamponade.Subsequent computed tomography (ct) on the following day revealed unchanged position of a fractured/migrated inferior vena cava filter prong.The tip of the prone appeared to be embedded within the intraventricular septum near the apex, possibly extending into the left ventricular apical lumen.Eventually a day later, computed tomography (ct) revealed fractured inferior vena cava filter with 2 of the struts embolized to the heart apex and hepatic segment 6 within the accessory inferior right hepatic lobe draining vein.No deep vein thrombosis within the inferior vena cava or imaged iliac/femoral veins was found.Therefore, the investigation is confirmed for the filter limb detachment.However the investigation is inconclusive for the alleged the filter migration and retrieval difficulties.Based on 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: 03/2011).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the entire filter migrated to heart and detached.The detached strut retained in right ventricle and liver.The device was removed after an attempted but unsuccessful percutaneous removal procedure.The detached strut has not been removed after an attempted but unsuccessful percutaneous removal procedure.The current status of the patient is unknown.

• Brand Name: G2 EXPRESS 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: 10060847
• MDR Text Key: 191102179
• Report Number: 2020394-2020-03405
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080668
• 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: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• 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: GFSC1037
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2008
• 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
• Treatment: EXCEDRIN MIGRAINE, VITAMIN B-12 AND HERB-A-LAX; EXCEDRIN, ANXIOLYTIC, ALFALFA AND VITAMIN-C; TYLENOL, COLACE, MELATONIN, ZOFRAN AND MIRALAX; ZINC PO, NYQUIL PO, CEPACOL, TUMS AND SENOKOT
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 57