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

Catalog Number RF320J

Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Date 10/12/2018

Event Type  Injury  

Manufacturer Narrative

The 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.Approximately one month later, patient presented with abdominal pain and distention.The study showed that inferior vena cava filter was noted at the level of l2.Approximately twelve years later, computed tomography revealed inferior vena cava filter was in place with several legs outside of the inferior vena cava, one adjacent to the aortic calcifications.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc).However, the investigation is inconclusive for filter tilt.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.

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 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 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: 11918600
• MDR Text Key: 253789172
• Report Number: 2020394-2021-80475
• 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: 06/02/2021

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 06/02/2021
• 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: ASCORBIC ACID, KETOCONAZOLE AND LACOSAMIDE; CYANOCOBALAMIN, POTASSIUM CHLORIDE AND PRAVASTATIN; GUAIFENESIN AND PYRIDOXINE; METOPROLOL, ALBUTEROL, FUROSEMIDE AND TIOTROPIUM
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 99