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

Catalog Number RF310F

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/25/2019

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 nine years and one month later, the patient presented for filter removal, right common femoral vein access and right internal jugular vein access were made.Inferior vena cavogram revealed the filter was tilted to the top right approximately 11 degrees.Multiple legs extend beyond the wall of the inferior vena cava.The filter was positioned below the level of the renal veins.Considering filter tilt and the lack of a hook along the top cap for snaring, the decision was made to use sterile rigid endobronchial forceps for retrieval.Rosen wire was advanced through the omni flush catheter which was exchanged for a 10-french dilator.The tract was dilated, and then serial dilation was performed up to 14-french.A 16-french by 45 cm sheath was flushed and advanced over the guidewire under fluoroscopic guidance into the inferior vena cava just above the superior aspect of the filter.Sterile bronchial forceps were placed through the sheath superior to the filter hook.The forceps were used to gently dissect the top cap of the filter off the wall of the cave.Multiple obliquities were used to guide the forceps exactly to the top cap.During dissection, one of the filter struts was noted to be bent superiorly.This strut was brought into the sheath and dissection continued.The filter top cap was grasped with the forceps and freed from the inferior vena cava wall.This allowed the sheath to be advanced over the filter and dislodged the legs from the inferior vena cava wall.The forceps and filter were removed through the sheath.The filter was inspected and one of the struts was noted to be absent.Gross description revealed, the filter was 4.0 x 3.5 x 3.5 cm.Fluoroscopy was then used to locate the strut which had embolized into the chest.Pulmonary arteriogram revealed the filter component embolization to the chest, with the embolized strut overlying the right upper lung/mediastinum, a 5-french catheter was advanced through the groin sheath and under fluoroscopic guidance advanced into the right ventricular outflow tract and into the main pulmonary artery.Digital subtraction angiography revealed patency of the right pulmonary arterial tree without evidence for strut embolization within the pulmonary artery.The strut appeared to be inferior to the right pulmonary artery.Superior venacavogram revealed the strut positioned posterior to the superior vena cava.On the next day, computed tomography angiography of cardiac revealed, the filter strut was extravascular in location, positioned in the mediastinal fat posterior to the left main pulmonary artery and extended inferolaterally with the distal strut abutted and closely associated with the posterior wall of the right superior pulmonary vein.The majority of the strut was stable to be extravascular, distal and inferior 7 mm portion of the filter strut intimately associated with the right superior pulmonary vein as a possible intravascular location.On the same day, computed tomography of chest without contrast revealed, the metallic fragment extends along the posterior aspect of the right superior pulmonary vein proximally and terminated in the mediastinum just anterior to the esophagus and immediately adjacent to the left atrium.Intraoperative consultation was requested from the cardiothoracic surgery service.Given the lack of additional movement of the embolized right and the patient's hemodynamic stability, the decision was made to terminate the procedure.Therefore, the investigation is confirmed for the alleged perforation of the inferior vena cava, filter limb detachment and material deformation.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: 09/2012).

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.Approximately nine years and one month post filter deployment, it was alleged that the filter struts perforated, bent superiorly, and detached.The device was removed percutaneously.The patient reportedly experienced embolized strut overlay the right upper lung/mediastinum; however, the current status of the patient is unknown.

• Brand Name: G2 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: 11981824
• MDR Text Key: 255592683
• Report Number: 2020394-2021-80502
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062887
• 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: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF310F
• Device Lot Number: GFTG3548
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2009
• 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): Required Intervention
• Patient Age: 34 YR
• Patient Weight: 53