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

Catalog Number RF310F

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685)

Event Date 10/29/2015

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 seven years and two months of post deployment, the patient was found to have a personal history of pulmonary embolism.On the same day, a computed tomography (ct) venogram showed 1 strut of the inferior vena cava filter extended into the duodenum and there was a doubt in the etiology of prior abdominal pain.Around three years and two months later, contiguous axial images using computed tomography (ct) abdomen and pelvis with intravenous and oral contrast showed that there was no evidence of inferior vena cava thrombosis.An infrarenal inferior vena cava filter was noted.At least 1 strut of the filter appeared to penetrate the wall of the inferior vena cava, and might have extend into the third portion of the duodenum or the periduodenal soft tissues.Therefore, the investigation is confirmed for the perforation of the ivc.Additionally, it can be confirmed that the patient experienced pe 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.(expiry date: 08/2011).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before bariatric procedure.At some time post filter deployment, it was alleged that the filter struts perforated into the organs.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: 12180731
• MDR Text Key: 261939142
• Report Number: 2020394-2021-80571
• 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: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• 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: GFSG3096
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2008
• 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: DIGOXIN AND ELIQUIS
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 58 YR