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

Catalog Number EC500F

Device Problem Extrusion (2934)

Patient Problem Great Vessel Perforation (2152)

Event Date 03/11/2015

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.This is the only event reported to date for this lot number and failure mode.Medical records review: the patient with multiple pulmonary embolisms and left femoral deep vein thrombosis had a vena cava filter successfully deployed below the level of the renal veins without incident.Approximately two years post filter deployment, a ct of abdomen and pelvis demonstrated the filter with several of the facets/footplate prongs extending slightly beyond the inferior vena cava (ivc) margin.No acute intra-abdominal or pelvic process was evident.Approximately seven months later, during scheduled retrieval, a cavogram demonstrated at least three of the filter prongs outside of the ivc margin.The filter was successfully retrieved using a snare device.The patient tolerated the procedure well, was admitted for monitoring and discharged three days later.Investigation summary: the device was not returned for evaluation.Images and medical records were provided and reviewed.Based on the image review and the medical records, the investigation can be confirmed for perforation of the ivc.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: potential complications: - perforation or other acute or chronic damage of the ivc wall the information provided by bard 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 bard.

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.At some time post filter deployment, it was alleged that the filter perforated the vena cava wall.The filter was removed percutaneously.The status of the patient is unknown.

• Brand Name: ECLIPSE 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7327171
• MDR Text Key: 101990525
• Report Number: 2020394-2018-00212
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 03/09/2018

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 Expiration Date: 08/31/2014
• Device Catalogue Number: EC500F
• Device Lot Number: GFVF4238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2011
• 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: WARFARIN
• Patient Outcome(s): Hospitalization
• Patient Age: 45 YR
• Patient Weight: 140