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

Catalog Number RF310F

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Cardiac Perforation (2513)

Event Date 08/22/2016

Event Type  Injury  

Manufacturer Narrative

A lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately nine years and ten months post filter deployment,a computed tomography chest without contrast showed that several metallic linear densities were identified in the left lower hemithorax and were consistent with inferior vena cava filter strut fragments.The largest inferior vena cava filter fragment measured approximately 4.0 cm in length was positioned along the pericardium, inferior to the heart.There was a rim of soft tissue attenuation around this fragment, consistent with pericardial thickening.Another inferior vena cava filter fragment measured approximately 1.0 cm was positioned within the pericardial sac anterior to the pulmonary trunk.A small inferior vena cava filter strut fragment measured less than 0.2 cm was within the lingula.An inferior vena cava filter fragment measured approximately 3.0 cm was within a subsegmental pulmonary artery of the left lower lobe and was best visualized on coronal imaging.There had been interval change in position of the filter fragment noted inferior to the heart, when compared to prior chest radiograph.Therefore, the investigation is confirmed for detachment of the inferior vena cava (ivc).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.Approximately nine years and ten months post filter deployment, a computed tomography (ct) chest without contrast alleged that the filter struts detached.The detached struts were found in the left lower hemithorax, pericardium, pericardial sac, lingula and sub-segmental pulmonary artery of the left lower lobe.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 - FEMORAL
• 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: 10579747
• MDR Text Key: 208319576
• Report Number: 2020394-2020-05804
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062887
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF310F
• Device Lot Number: GFQE4634
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2020
• 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: CIPRO, DULCOLAX AND GLUCOPHAGE; COUMADIN, LOVENOX, FLOMAX, ACTONEL AND PREDNISONE; PEPCID, COLACE, CALCIUM CARBONATE AND UROCHOLINE
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 136