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

Catalog Number EC500F

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

Patient Problem Pulmonary Embolism (1498)

Event Date 04/25/2014

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 nine months later, the patient presented for filter removal, vena cavogram showed the filter with angulation with the nose cone of the filter basically appeared to be embedded within the wall of the vena cava.Multiple attempted made to snare the filter, but unsuccessful.The filter appeared to be closely associated with the wall of the vena cava.Also attempted to straighten the filter with angioplasty balloon and then also attempted the nose cone recovery system from bard medical and were unsuccessful in being able to completely capture the filter.Again, multiple attempts were made and despite aggressive attempts at grasping the filter, it appeared that the patient had some fibrin sheath that had grown around the hook on the filter.There was no thrombus, but there was a filling defect on the lateral wall of the cava that again appeared primarily to be intimal hyperplasia.After one month later, the patient presented second attempt to remove the filter via femoral approach.Vena cavogram showed the filter in the mid inferior vena cava with angulation.The nose cone of the filter appeared to be somewhat embedded into the wall of the vena cava.Passed a wire through the filter and multiple attempts were made to snare the filter and pulled the filter from the wall of the vena cava, but it was unsuccessful.Used multiple wires and catheters, but unable to completely decompress the filter.It was not safe to continue to try to remove the filter as there was some concern for filter fracture as well as a possible vena cava injury.Open operation required for filter removal.After one year and six months later, computed tomography angiogram of chest with and without contrast revealed filling defect throughout segmental branches of the right lower lobe.There was possibly a smaller embolus throughout pulmonary arteries of the left lower lobe.After three years and three months later, computed tomography of the abdomen without contrast revealed, the filter was located in the inferior vena cava, below the renal veins and above the iliac vein confluence.The long axis of the filter was tilted 12 degrees relative to the long axis of the inferior vena cava.The proximal head of the filter abutted the right lateral inferior vena cava wall, there was no deformity of the metallic filter struts.One of the struts penetrated the left lateral wall of the inferior vena cava and the right wall of the abdominal aorta, protruded 6 mm into the aortic lumen.A second stress penetrated the left posterolateral inferior vena cava wall and protruded 18 mm, passed behind the aorta.A posterior strut protruded 14 mm beyond the inferior vena cava wall, contacted the anterior/superior vertebral body.Two anterior struts protruded 6 mm and 8 mm, respectively, into the periaortic fat.Therefore, the investigation is confirmed for perforation of the inferior vena cava and retrieval difficulties.Additionally, it can be confirmed that the patient experienced pulmonary embolism 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: 09/2014).

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, and pulmonary embolism.Approximately nine months later, post filter deployment, it was alleged that the filter struts perforated the inferior vena cava (ivc).The device has not been removed after multiple attempts.The patient reportedly 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: 10546423
• MDR Text Key: 207314871
• Report Number: 2020394-2020-05676
• 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: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: GFVH1391
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/17/2020
• 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
• Treatment: METFORMIN; TESTOSTERONE, FENOFIBRIC ACID, FENOFIBRATE; WARFARIN, ENOXAPARIN, ASPIRIN
• Patient Outcome(s): Life Threatening
• Patient Age: 41 YR
• Patient Weight: 120