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

Catalog Number EC500F

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 03/06/2016

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 four years and one month later of post filter deployment a computed tomography shows multiple legs of the filter protruded out of the inferior vena cava; some of the legs were in contact with l2 vertebral body.Eventually on the next day a computed tomography shows the filter with multiple legs protruded out of the inferior vena cava; some of these legs were in contact with l2 vertebral body.During discharge, the patient experienced chronic back pain.Approximately around four week and two days, again a computed tomography has demonstrated and it shows the filter with several of the legs external to the wall of the inferior vena cava; however, there was no evidence of surrounding inflammatory change or pericaval fluid collection.After one month later again a computed tomography has performed and the filter has with multiple legs extended beyond the inferior vena cava.Sequentially after three days a computed tomography shows the filter prongs extended beyond the wall of the inferior vena cava, unchanged.Around four months later again a computer tomography shows the some of the struts of the filter appeared to project beyond the lumen of the inferior vena cava.Therefore, the investigation is confirmed for perforation of the inferior vena cava.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: 11/2014).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep venous thrombosis, pulmonary embolism and necrotizing pancreatitis.Approximately four years and one month post filter deployment, a computed tomography (ct) abdomen and pelvis with intravenous contrast alleged that the filter struts perforated.The patient reportedly experienced chronic back pain and abdominal pain.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: 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 ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10533495
• MDR Text Key: 206938087
• Report Number: 2020394-2020-05641
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EC500F
• Device Lot Number: GFVK0313
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2020
• 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: SENNA; ZOFRAN, MORPHINE, BENADRYL, DILAUDID AND COLACE
• Patient Outcome(s): Other
• Patient Age: 56 YR