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

Catalog Number EC500F

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

Patient Problem Abdominal Pain (1685)

Event Date 03/09/2014

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-month post filter deployment, patient presented with right lower quadrant pain.Subsequent computed tomography (ct) revealed that there was an inferior vena cava filter in place.One of the struts perforates the posterior wall of the inferior vena cava.Eventually three years and five months post filter deployment, computed tomography (ct) revealed that one of the filter legs on the left side was penetrated through the wall of the inferior vena cava and appears discontinuous and was likely fractured.The filter was tilted to the left with its cone near the wall of the inferior vena cava.All the arms and legs of the filter have penetrated through the wall of the inferior vena cava into the pericaval/mesenteric fat.One of the legs was in contact with the right lateral wall of the abdominal aorta possibly penetrating into it.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc) and filter tilt.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: 08/2016).

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 struts perforated and tilted.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced right lower quadrant pain; however, 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: 10527492
• MDR Text Key: 206748339
• Report Number: 2020394-2020-05630
• 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: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• 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: GFXG3684
• 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
• Patient Outcome(s): Other
• Patient Age: 41 YR