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

Catalog Number UNKNOWN G2

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Malposition of Device (2616)

Patient Problems Chest Pain (1776); Death (1802); Cardiac Perforation (2513)

Event Date 08/31/2009

Event Type  Death  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.((b)(4)).

Event Description

It was reported through the litigation process that a vena cava filter was placed prophylactically prior to gastric bypass surgery.Approximately six years and eleven months post filter deployment, it was alleged that the filter tilted, migrated, struts perforated the inferior vena cava and struts detached.The detached struts retained in both right and left ventricle and patient reportedly experience chest pain.The patient reportedly expired.

Event Description

It was reported through the litigation process that a vena cava filter was placed prophylactically prior to gastric bypass surgery.Approximately six years and eleven months post filter deployment, it was alleged that the filter tilted, migrated, struts perforated the inferior vena cava and struts detached.The detached struts retained in both right and left ventricle and patient reportedly experienced chest pain.The patient reportedly expired.

Manufacturer Narrative

Manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Bard g2 filter was implanted with the tip at l2 for a patient.Approximately twenty-two days later, computed tomography (ct) revealed that the filter migrated in a cephalad direction about two vertebral body lengths which measures to be about 6.5 cm.Approximately eight months later, the patient presented for filter removal, venacavagram showed the filter nose appeared to be located at the level of t12 to t13 vertebral interspace level, there was no evidence of extravasation and clot in the filter.Repeated attempts were made to retrieve the filter; however, the filter could not be detached from the vein and the procedure was aborted.Eventually five months later, the patient hospitalized for motor vehicle accident and computed tomography (ct) revealed no metallic foreign body within the chest.The nose of the filter was tilted to the left and terminated at the level of the superior endplate of the t13 vertebral body, which was just above the insertion of the left renal vein into the inferior vena cava.Six arms and six legs were intact, although two legs were entered the lower right renal vein, and two arms are entered the upper right renal vein.Approximately four years and nine months later, computed tomography (ct) revealed linear metallic densities within the right ventricle of the heart.The filter was tilted to the left, with the nose embedded within the wall of the inferior vena cava just above the insertion of the left renal vein into the inferior vena cava.The nose appeared to be terminated at the level of the inferior end plate of the t12 vertebral body.Multiple grade 1 and 2 penetrations of struts were evident.On the left, one arm was entered the left renal vein.On the right, the renal vein was duplicated.One arm was entered the upper right renal vein, and one leg was entered the lower right renal vein.Only four arms and five legs can be identified within the inferior vena cava, but two struts twisted together could be easily mistaken for one strut, due to diminished clarity of the scan from the large size of the patient.Possibly two struts had fractured and embolized to the right ventricle of the heart.An additional fragment may be embolized to a left pulmonary artery branch.The fragment or fragments in the right ventricle of the heart may be embedded and contained within the myocardium of the anterior wall of the right ventricle.The diameter of the inferior vena cava was 3 cm, which was above the limit of 28 mm, oversized inferior vena cave likely contributed the cephalad migration of the filter, which allowed struts to become displaced into the renal veins.This likely caused the filter to become tilted with the nose embedded into the wall of the inferior vena cava above the insertion of the left renal vein.This caused the filter to migrate superiorly, with displacement of several limbs of the filter into the upper and lower right renal vein.This could have contributed to a fracture of one, two, or three limbs, with subsequent embolization of the fractured fragments to the right ventricle of the heart and possibly a pulmonary artery branch.The complications result in placed the filter into an inferior vena cava larger than recommended include filter migration and tilt, with potential filter embolization to the heart, which has been associated with sudden death.Therefore, the investigation is confirmed for filter tilt, perforation of the inferior vena cava (ivc), material deformation, filter limb detachment, retrieval difficulties and filter migration.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.

• Brand Name: G2 FILTER SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10598518
• MDR Text Key: 208904110
• Report Number: 2020394-2020-05844
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN G2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 25 YR