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

Catalog Number RF320J

Device Problems Obstruction of Flow (2423); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

Patient Problem Abdominal Pain (1685)

Event Date 08/23/2014

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, six years and seven months post deployment the patient was recently diagnosed with a blocked inferior vena cava filter.Around, three years and ten months later, x-ray of pelvis was performed which showed inferior vena cava filter.After, eighteen days, computed tomography of lumbar spine without contrast was performed for lumbar spinal stenosis which showed inferior vena cava filter identified at the level of l3-l4.One of the legs of this filter appears to be broken and lodged in the l3-l4 intervertebral disc.This does not affect the spinal canal.Around, sixteen days, the patient experienced abdominal pain, x-ray of abdomen was performed which revealed an inferior vena cava filter at the l3 vertebral level.On the next day, the patient experienced abdominal pain, computed tomography of abdomen and pelvis without contrast was performed which showed inferior vena cava filter terminates below the level of the renal veins.Collapsed inferior vena cava and iliac vessels upstream from the inferior vena cava filter.Therefore, the investigation is confirmed for occlusion of the inferior vena cava (ivc).However, the investigation is inconclusive for the perforation of the inferior vena cava (ivc) and filter limb detachment.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.(expiry date: 10/2010).

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 and pulmonary embolus with gastrointestinal bleeding.At some time, post filter deployment, it was alleged that the filter occluded, struts perforated, detached, and the patient reportedly experienced abdominal pain.The device has not been removed and there were no reported attempts made to retrieve the filter.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: 12342239
• MDR Text Key: 267261488
• Report Number: 2020394-2021-80705
• 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: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• 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: GFRI3360
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2007
• 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: ATORVASTATIN, CEPHALEXIN, DOCUSATE SODIUM; COUMADIN, ACETAMINOPHEN, ALLOPURINOL, APIXABAN; DULOXETINE, FOLIC ACID, GABAPENTIN; LEVOTHYROXINE, LIDOCAINE, METOPROLOL TARTRATE; ONDANSETRON, OXYBUTYNIN, OXYCODONE, PILOCARPINE; POLYETHYLENE GLYCOL, PREDNISONE; SODIUM BICARBONATE, TORSEMIDE; SODIUM THIOSULFATE AND QUETIAPINE
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 96