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); Detachment of Device or Device Component (2907); Material Deformation (2976); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problem Pulmonary Embolism (1498)

Event Date 10/04/2012

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately six months later, a computed tomogram angiogram of chest was performed for history of shortness of breath.The study showed small linear filling defect in the proximal left upper lobe pulmonary artery that appears to represent possibly an old fibrin clot.On the next day, patient was planned for filter removal.Through the right jugular vein approach, a venogram was performed.Inferior vena cava filter hook ingrown into the inferior vena cava wall and unable to remove the filter.After one year, a computed tomogram angiogram of chest was performed for shortness of breath.The study showed that small amount of thrombus in the lateral aspect of the right and left main pulmonary artery.This extends into the proximal portion of the right and left upper lobe pulmonary arteries and the right and left lower lobe pulmonary arteries.The findings are consistent with pulmonary embolism.After eight months, patient presented with the complaints of shortness of breath.A computed tomography angiogram of chest was performed which showed negative for pulmonary embolism.After seven months, patient presented with the complaints of low back pain and leg pain.Patient was planned for lumbar laminectomy procedure.An x-ray lumbar spine was performed which showed inferior vena cava filter was noted.After three months, an x-ray lumbar spine was performed which showed inferior vena cava filter projects at the l2-l3 level.Filter tilted towards the left side and a fractured strut identified extending cephalad to the tip of the filter.After two months, an x-ray lumbar spine was performed which showed partially visualized inferior vena cava filter which was tilted but unchanged.After one year and eleven months, a computed tomography of abdomen was performed for filter evaluation.The study showed that inferior vena cava filter was noted with the tip roughly at 3 cm inferior to the left renal vein.The filter was tilted to the right with the cone of the filter penetrating through the wall of the inferior vena cava into the pericaval/mesenteric fat.There was a prong bent superiorly and extending outside the medial wall of the inferior vena cava into the retroperitoneum.One of the arms of the filter was fractured off of the filter.It was positioned in the inferior vena cava immediately superior to the cone of the filter and extends through the left lateral wall of the inferior vena cava into the pericaval/mesenteric fat.One of the legs of the filter penetrates through the wall of the inferior vena cava into the mid lumen of the abdominal aorta.Several other legs of the filter have penetrated through the wall of the inferior vena cava into the pericaval/mesenteric fat.Therefore, the investigation is confirmed for the alleged filter limb detachment, perforation of the inferior vena cava, filter migration, material deformation 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.

Event Description

It was reported through the litigation process that a vena cava filter was placed and the reason for deployment was not provided.At some time post filter deployment, it was alleged that the filter tilted, migrated, strut detached and perforated the vena cava wall, mesentery and aorta.The device has not been removed after an unsuccessful attempt.The detached strut retained in inferior vena cava.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: 12065489
• MDR Text Key: 258299738
• Report Number: 2020394-2021-80528
• 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: 06/25/2021

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 06/25/2021
• 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
• Treatment: CARDIZEM, NITROGLYCERIN AND WARFARIN; OMEPRAZOLE, LASIX AND NORCO; RESTORIL, DICLOFENAC AND PROZAC
• Patient Outcome(s): Life Threatening
• Patient Age: 73 YR
• Patient Weight: 114