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

Catalog Number RF320J

Device Problems Obstruction of Flow (2423); Malposition of Device (2616); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Thrombosis/Thrombus (4440)

Event Date 12/23/2013

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately seven years and seven months later, the patient was diagnosed with a thrombotic occlusion of the inferior vena cava filter, after an inferior vena cavogram.It was noted that the filter was somewhat deformed from the beginning with the legs splayed on the lateral edge of the filter.Nonetheless, it appeared to be functional.On the same day, patient underwent thrombolysis catheter placement and bolus of tissue plasminogen activator through thrombolysis catheter.On the next day, the patient underwent mechanical thrombectomy using angio jet device and cleaner device in the left iliac vein and inferior vena cava.After one week, the patient¿s history of present illness stated that the patient had an inferior vena cava occlusion at the level of the existing inferior vena cava filter.After two months and three weeks, a computed tomography angiography (cta) abdomen and pelvis showed that there was an inferior vena cava filter with spokes of the filter penetrated through the wall of the inferior vena cava.There was no hematoma around the inferior vena cava.The inferior vena cava was contracted around the filter.There was thrombus noted in the right common iliac vein.After two weeks, the patient presented with chief complaint of thrombosis of the filter-bearing inferior vena cava.After four days, the patient presented with lower abdominal pain.On the same day, a computed tomography (ct) abdomen and pelvis with intravenous contrast showed an infra renal bard inferior vena cava filter with tip embedded against the posterior caval wall.Some of the legs protruded beyond the expected confines of the caval walls.The filter was complicated by multifocal penetration into the retroperitoneum, adjacent psoas muscle, adjacent vertebral body, and retroaortic space.There was chronic total occlusion of the right common iliac vein.There was possible stenosis along the left common and external iliac veins.There was no acute thrombus.There was moderate to severe inferior vena cava stenosis at the filter apex.There was no evidence of perforation, abscess or free fluid in the pelvis.After three months, an attempt was made to retrieve the filter from the patient¿s body.Initial scout fluoroscopic image demonstrated an intact bard recovery inferior vena cava filter.Left iliocaval venogram demonstrated a patent left iliofemoral venous system with no large filling defect.At least 3 arms and 2 legs of the inferior vena cava filter penetrated beyond the lumen of the inferior vena cava.Under ultrasound guidance, a micropuncture set was used to access the right internal jugular vein.The sheath was retracted into the suprarenal inferior vena cava and rigid forceps were advanced through the sheath and used to dissect free the embedded apex of the filter.Sequential images demonstrated sheathing and removal of the inferior vena cava filter.The filter was removed in its entirety.The filter was visually inspected.Therefore, the investigation is confirmed for the alleged material deformation, perforation of the inferior vena cava, filter occlusion and filter tilt.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.However, the relationship to the filter is unknown.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.

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 filter tilted, clogged and struts perforated into organs.The device was removed percutaneously.The patient experienced abdominal pain, however; the current status of the patient is unknown.

• Brand Name: G2 FILTER SYSTEM - JUGULAR
• 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: 12195937
• MDR Text Key: 262420759
• Report Number: 2020394-2021-80605
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052578
• 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: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF320J
• Device Lot Number: GFQA1497
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: COUMADIN, ASPIRIN, LORTAB AND PERCOCET; MELOXICAM AND SKELAXIN
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 107