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

Catalog Number EC500F

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problems Chest Pain (1776); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 09/02/2015

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 (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately four years post filter deployment, computed tomography revealed a metallic wire that penetrates the right ventricular wall.Transthoracic echocardiogram and left heart catheterization were done on the same day which showed there was a small pericardial effusion and foreign object noted on the right ventricle by ischemic evaluation and abnormal electrocardiogram found by 12-lead ekg.An assessment was made the foreign body inferior vena cava filter fragment perforating right ventricle.Subsequently, next day patient was admitted due to chest pain.Computed tomography performed revealed a metallic wire in right ventricle penetrating the right ventricle wall.The patient was scheduled for filter fragment retrieval.The filter fragment was attempted to be retrieved through right femoral and jugular vein access.After numerous unsuccessful attempts, it was not possible to remove the filter fragment from the heart, then procedure was aborted.Approximately, a few days later, the fragment was retrieved successfully.Therefore, the investigation is confirmed for filter limb detachment.However, the investigation is inconclusive for retrieval difficulties.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.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter detached.The device and detached filter components were removed percutaneously.Prior to the device and detached filter components being removed there was an attempted but unsuccessful percutaneous removal procedure.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: 10166009
• MDR Text Key: 195536397
• Report Number: 2020394-2020-03969
• 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: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2014
• Device Catalogue Number: EC500F
• Device Lot Number: GFVA2437
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2011
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 52 YR