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

Catalog Number RF320J

Device Problems Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682); Material Deformation (2976)

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

Event Date 12/24/2009

Event Type  Injury  

Manufacturer Narrative

A device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately one month of post deployment, a computed tomography angiography of chest was performed for chest pain.The study showed that inferior vena cava filter was in place.Pulmonary emboli were noted in the right upper lobe and lower lobes from the previous exam.There are small residual filling defects within the lower lobes and no new filling defects were noted within the main, right and left pulmonary arteries or branches.The next day, a computed tomography of abdomen and pelvis was performed which showed inferior vena cava filter was present at the level of l1-2 to mid l3.Infrarenal with inferior vena cava thrombosed below renal veins.Positive for grade 1 perforation and migration.No significant tilt was noted.Extensive clot filling the inferior vena cava below the level of the filter with some extension above the filter.Craniocaudal dimension of the clot extension above the filter.Two months later, a magnetic resonance venography of abdomen was performed for inferior vena cava thrombosis.The study showed that complete thrombosis of the inferior vena cava below the right renal vein.A computed tomography angiogram of chest was performed for follow up pulmonary nodule.The study showed that poor opacification making the study very limited for evaluation of pulmonary arteries.Seven years and three months later, a computed tomography angiogram of abdomen and pelvis was performed for filter evaluation.The study showed inferior vena cava filter was noted at the l2-l3 to mid l4 level without any significant tilt.Grade 1 perforation and compressed inferior vena cava filter was noted.There was significant migration approximately 15 mm caudal with respect to mid right renal vein.Inferior vena cava attenuated probably secondary to chronic thrombosis.Therefore the investigation is confirmed for perforation of the inferior vena cava (ivc), material deformation and filter migration.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 was compressed, significantly migrated and struts perforated the inferior vena cava.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient was diagnosed with thrombosis and reportedly 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: 12015839
• MDR Text Key: 256705521
• Report Number: 2020394-2021-80513
• 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: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 83