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

Catalog Number EC500F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Death (1802)

Event Date 09/27/2010

Event Type  Death  

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.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately one month later, patient experienced abdominal pain.Subsequent, ct revealed two of the ivc filter arms have traversed the ivc and the filter was found to be tilted in the ivc.Two or three legs of the filter were extra luminal.The tip of the filter was up against the wall of the vena cava.The attempts to grab the filter using sheath and snare were unsuccessful as the filter was up against the wall.Next a biplane and snare device was used to grasp the tip.This was also unsuccessful as this could not be placed around the tip.Eventually, the filter was pulled out in its entirety using french cobra shaped sheath.Therefore, the investigation is confirmed for perforation of the ivc, filter tilt and retrieval difficulties.Per medical records, multiple attempts were made to engage the filter using snare and sheath but were unsuccessful due to filter tilt.This could have contributed to the retrieval difficulties.However, 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: 06/2013).

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 tilted and embedded in the wall of ivc and struts perforated.The device was removed percutaneously.The patient reportedly expired.

• 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: 9486238
• MDR Text Key: 171775115
• Report Number: 2020394-2019-05674
• 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: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• 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: GFUD2533
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2010
• 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): Death; Other
• Patient Age: 38 YR