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

Catalog Number RF310F

Device Problem Difficult to Remove (1528)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 12/02/2009

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: 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 seven months of post deployment, venogram was performed which showed thrombus in the cava upto including the inferior vena cava filter extending slightly upto above the inferior vena cava filter but stopping before getting upto the renal veins.The next day, ekosonic endovascular system thrombolysis and thrombus aspiration from inferior vena cava filter was performed.Post ekos thrombolysis completion venogram was performed which showed the inferior vena cava was now widely patent except for some residual thrombus left in the inferior vena cava filter for a patient with caval iliofemoral thrombosis.Around five months later, inferior vena cava filter retrieval was performed.The retrieval capture device was advanced down over the filter and then with the usual maneuvers, the filter was retrieved into the sheath and pulled out of the patient.Completion venogram showed normal looking inferior vena cava.The patient tolerated the procedure without problems.Therefore, the investigation is inconclusive for retrieval difficulties.Additionally, it can be confirmed that the patient experienced thrombus above the level of filter post deployment.However, the relationship to the filter is unknown.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: 03/2012).

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.The device was removed percutaneously after an attempted but unsuccessful percutaneous removal procedure.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: 12201335
• MDR Text Key: 262629893
• Report Number: 2020394-2021-80663
• 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: 07/21/2021

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: RF310F
• Device Lot Number: GFTB0035
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/21/2021
• 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: ROCEPHIN, COUMADIN AND HEPARIN
• Patient Outcome(s): Other
• Patient Age: 49 YR