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

Catalog Number RF400J

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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, nine years ten months of post deployment, a computed tomography of the abdomen and pelvis was performed.The images displayed the filter with the superior tip located at the level of the most inferior renal vein located on the left side.The inferior vena cava is tortuous, and the inferior vena cava filter therefore appeared to be slightly tilted.Multiple prongs were projecting out the lumen of the filter.The anterior prongs were projecting outside of the lumen of the inferior vena cava and were specifically projecting in the duodenum located anteriorly.To the left side, the prong located at the 2 o¿clock position seemed to be projecting at the anterior wall of the abdominal aorta.Posteriorly, prongs located at the 4 o¿clock and 8 o¿clock position appeared to be projecting outside of the lumen just anterior to the vertebral bodies.There was evidence for prongs located on the right side which were projecting to the right side of the renal hilum.The filter was located at the right side of the l2 and l3 vertebral bodies.It appeared to be located approximately 3.9 centimeters above the bifurcation of the inferior vena cava.Therefore, the investigation is confirmed for the perforation of the inferior vena cava (ivc).However, the investigation is inconclusive for filter tilt, filter limb detachment 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.(expiry date: 06/2011).

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, migrated to heart, struts perforated and detached.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient was unknown.

• Brand Name: G2 EXPRESS 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: 12352342
• MDR Text Key: 267623859
• Report Number: 2020394-2021-80706
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080668
• 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: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF400J
• Device Lot Number: GFSC1173
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2008
• 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: GLYBURIDE, HYDROCHLOROTHIAZIDE; MELOXICAM, AND METFORMIN; NORVASC, ONGLYZA, ZOCOR, CANAGLIFLOZIN
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 87