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 Pulmonary Embolism (1498)

Event Date 08/18/2016

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.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately three years and ten months of post deployment, patient presented with the complaints of chest pain.A computed tomography angiogram of chest was performed which showed moderately large bilateral pulmonary thromboembolism.Around one year and three months later, a computed tomography of abdomen was performed for filter evaluation.The study showed that inferior vena cava filter was noted at the level of renal veins.The filter was somewhat tilted with the cephalad aspect likely abutting the right lateral wall of the inferior vena cava.The struts extend beyond the lumen of the inferior vena cava with a strut at approximately 7 o¿clock likely extending into the right psoas muscle.Remaining struts extend minimally into the adjacent fat.Therefore, the investigation is confirmed for perforation of inferior vena cava (ivc) and filter tilt.Additionally, it can be confirmed that the patient experienced pe post deployment.However, the relationship to the filter is unknown.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: 06/2015).

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.Approximately five years and two months post filter deployment, a computed tomography scan showed that the filter tilted and perforated the inferior vena cava with one strut perforating into the psoas muscle.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient was diagnosed with pulmonary embolism post implant; 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: 12237113
• MDR Text Key: 263809971
• Report Number: 2020394-2021-80676
• 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: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• 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: GFWE3382
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2012
• 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: ASPIRIN, LEVAQUIN AND LOVENOX; MORPHINE SULFATE AND TYLENOL
• Patient Outcome(s): Life Threatening
• Patient Age: 43 YR
• Patient Weight: 78