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

Catalog Number RF310F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Thrombus (2101)

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 (dhr) review is not required.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately nine years later, computed tomography revealed that few tines of filter extending into the lumen abutting the duodenum and aorta.Subsequently eight months later computed tomography revealed that redemonstration of infrarenal inferior vena cava filter with tines extending beyond the caval lumen.Eventually five days later, filter retrieval was scheduled but it was able to partially removed.Approximately twenty one days later patient suffered with low back pain and an x-ray was done for lumbar spine and it revealed that filter was present with 2 of the legs extending superiorly.Subsequently eight days later patient suffered with abdominal pain so x- ray was performed, it revealed that filter projecting over the expected location of the infrarenal inferior vena cava and two of the limbs of the filter were noted to be directed towards right upper quadrant.Approximately fourteen days later patient presented for post failed filter removal, mr venogram showed the suprarenal inferior vena cava was small in caliber but questionable thin internal filling defect versus flow artifact but no occlusion was seen.No occlusion was apparent within the inferior vena cava below the filter or in the bilateral iliac veins.Therefore, the investigation is confirmed for alleged perforation of the ivc, retrieval difficulties and material deformation.However, the investigation is inconclusive for filter tilt.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.However, the relationship to the filter is unknown.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.((b)(4), (expiry date: 04/2012).

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.Approximately nine years and eight months post filter deployment, a computed tomography demonstrated that multiple filter limbs perforated the ivc.It was further alleged that the filter tilted and embedded in wall of the ivc.The device was removed 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: 10244405
• MDR Text Key: 197940443
• Report Number: 2020394-2020-04357
• 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: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• 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: GFTB3609
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2020
• 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
• Patient Outcome(s): Other