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

Catalog Number RF310F

Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problem Pulmonary Embolism (1498)

Event Date 04/04/2018

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 eight years later, computed tomography of the abdomen and pelvis without contrast revealed the filter was tilted within the inferior vena cava with the apex of the filter abutted the left anterolateral wall of the inferior vena cava.Coronal and axial images demonstrate penetration of 2 struts of the filter posteriorly, abutted or penetrated the right paraspinal musculature and right-sided renal vasculature.The patient still had pulmonary embolism while the filter was in place.After one month, the patient presented for filter removal.An access made via right internal jugular vein by ultrasound guidance.Under fluoroscopic guidance a catheter and wire were manipulated into the inferior vena cava.Using a sheath and endobronchial forceps, snare the g2 filter and removed successfully under fluoroscopic guidance and one strut was not retrieved.After six days, computed tomography of the abdomen and pelvis without contrast revealed there appears to be a single retained strut from the patient's filter adjacent to the inferior vena cava along its left lateral aspect.Therefore, the investigation is confirmed for alleged filter tilt, perforation of the inferior vena cava, and filter limb detachment.Additionally, it can be confirmed that the patient experienced pulmonary embolism 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: 11/2012).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with morbid obesity and high risk for deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that filter tilted and two struts perforated posteriorly abutting or penetrating the right paraspinal musculature and right-sided renal vasculature.The device was removed percutaneously.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: 11099419
• MDR Text Key: 224526601
• Report Number: 2020394-2020-06516
• 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: 12/30/2020

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: GFTJ1627
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/30/2020
• 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: PLAVIX
• Patient Outcome(s): Life Threatening
• Patient Age: 60 YR