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

Catalog Number RF320J

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pulmonary Embolism (1498)

Event Date 03/16/2009

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 09/2011).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with pulmonary emboli.At some time post filter deployment, a computed tomography (ct) abdomen and pelvis with contrast showed that some of the distal prongs were seen outside the lumen of the inferior vena cava, within the mesenteric fat and abutted near the distal abdominal aorta.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient was diagnosed with pulmonary embolism post implant; however, the current status of the patient is unknown.

Manufacturer Narrative

H10: 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 three months later, the patient suffered from chest pain and history of pulmonary emboli.On the same day, axial images using computed tomography angiography (cta) of the chest with intravenous contrast and image post-processing showed extensive thrombus formation in the right upper, right middle and right lower lobes.There was no pulmonary embolism on the left lobe.This could have been chronic in nature.Acute embolism cannot be totally excluded.After eight years and four months later, a computed tomography (ct) abdomen and pelvis with contrast showed that an inferior vena cava filter was noted with some of the distal prongs seen outside the lumen of the inferior vena cava, within the mesenteric fat and abutted near the distal abdominal aorta.Therefore, the investigation is confirmed for alleged perforation of the inferior vena cava.Additionally, it can be confirmed that the patient experienced pulmonary embolism 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.H10: d4(expiry date: 09/2011), g4.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with pulmonary emboli.At some time post filter deployment, a computed tomography (ct) abdomen and pelvis with contrast showed that some of the distal prongs were seen outside the lumen of the inferior vena cava, within the mesenteric fat and abutted near the distal abdominal aorta.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient was diagnosed with pulmonary embolism post implant; 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
• MDR Report Key: 11277383
• MDR Text Key: 230220356
• Report Number: 2020394-2021-80146
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K052578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• 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: GFSH2015
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 55 YR