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

Catalog Number RF400F

Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)

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

Event Date 08/10/2010

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 one year and five months, post filter deployment computed tomography revealed right lower lobe subsegmental intraluminal filling defect suggests pulmonary embolus.Approximately two months later, computed tomography revealed right lower lobe subsegmental pulmonary embolus.Approximately one month later, computed tomography revealed right lower lobe subsegmental pulmonary arterial filling defect consistent.Approximately one year later, computed tomography revealed a small subsegmental intraluminal filling defect was seen in the right lower lobe.Approximately seven years later, computed tomography revealed the filter nose touched the right lateral wall at the level below the renal vessels with approximately 17 degrees of tilt.One leg extends through the left anterior wall extended 1 cm to the level anterior to the aorta.One posterior leg extends along the posterior wall of the aorta approximately 1.6 cm from the inferior vena cava wall.One leg from the mid left lateral wall extends 1 mm into the right lateral aortic wall.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc) and filter tilt.Additionally, it can be confirmed that the patient experienced pulmonary embolism 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: 11/2011 the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with pulmonary embolism.At some time, post filter deployment, it was alleged that the filter tilted, and struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced abdominal pain and diagnosed with pulmonary embolism; however, the current status of the patient is unknown.

• Brand Name: G2 EXPRESS 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: 11377103
• MDR Text Key: 233452452
• Report Number: 2020394-2021-80200
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080668
• 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: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF400F
• Device Lot Number: GFSJ3305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2021
• 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: LIPITOR, CLONIDINE, SEROQUEL, LISINOPRIL, COUMADIN; LOVENOX, PRAVASTATIN, RANITIDINE, ALBUTEROL; MIRALAX, AND ZOFRAN
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 47 YR
• Patient Weight: 76