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

Catalog Number EC500F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Thrombosis/Thrombus (4440)

Event Date 08/15/2015

Event Type  Injury  

Manufacturer Narrative

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.Post filter deployment arteriogram study showed inferior vena cava filter was in place projecting at the inferior l2 level and inferior l3 level.Approximately one year and two months of post deployment, a magnetic resonance imaging of lumbar spine was performed for low back pain with left hip and leg pain.The study showed that inferior vena cava filter was noted that results in metallic susceptibility artifact.One year and five months later, patient presented with the complaints of chest pain and shortness of breath.Patient was sent to emergency room to rule out pulmonary embolism.Five months later, patient presented with the complaints of chest pain and back pain.X-ray was performed which showed normal study.Two years and five months later, a computed tomography of lumbar spine was performed for severe back pain.The study showed that inferior vena cava filter was noted.Nine days later, patient presented with the complaints of bilateral leg swelling, back pain and abdominal pain.An x-ray abdomen was performed for abdominal pain which showed, inferior vena cava filter was noted.A computed tomography angiogram of chest was performed for leg swelling.The study showed that non-occluding pulmonary emboli within the left lower lobe lateral basal segment pulmonary artery.There are no central or large peripheral pulmonary emboli.A computed tomography of lumbar spine was performed for severe back pain.The study showed that inferior vena cava filter was noted.The next day, patient underwent bilateral lower extremities venogram which showed extensive thrombus/clots starting at the level of inferior vena cava filter and extend to bilateral iliac and femoral veins.Partial thrombolysis of bilateral femoral, iliac and distal inferior vena cava at and below the inferior vena cava filter with tissue plasminogen activator (tpa) and angiojet with placement of infusion catheter.The next day, patient had follow-up bilateral lower extremities venogram.There was moderate clearing of abnormal filling defects seen at the bilateral femoral and iliac vein with some clearing of distal inferior vena cava.Mechanical thrombectomy was performed along the entire length of bilateral femoral, iliac and distal inferior vena cava.Follow-up venogram demonstrated significant clearing of clots/thrombus along bilateral femoral and iliac veins.However, there was still moderate amount of thrombus still persists at left common iliac vein/distal inferior vena cava junction.One month later, patient presented with the complaints of back pain and fever.A computed tomography of abdomen and pelvis was performed for low back pain.The study showed that inferior vena cava filter was noted.One year later, patient presented with the complaints of right sided lower abdominal pain.A computed tomography of abdomen and pelvis was performed which showed inferior vena cava filter was noted.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter.Additionally, it can be confirmed that the patient experienced pulmonary embolism and thrombus 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: 01/2013).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with hypercoagulable state and deep vein thrombosis.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient was diagnosed with pulmonary embolism and thrombus at the level of filter; 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: 11973094
• MDR Text Key: 255678699
• Report Number: 2020394-2021-80490
• 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: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• 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: GFUA1882
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2021
• 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): Life Threatening; Other
• Patient Age: 45 YR
• Patient Weight: 130