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); Patient-Device Incompatibility (2682); Material Deformation (2976)

Patient Problem Pulmonary Embolism (1498)

Event Date 06/10/2013

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 two months later, the patient scheduled for the filter retrieval, the right internal jugular vein was accessed.Multiple attempts to snare the retrieval hook were unsuccessful.Additional attempts to retrieve the filter were made with a 25cm loop snare again without success.Bankart catheter were advanced to the sheath and using gentle traction on both ends of the wire, attempts to sheath the filter were unsuccessful.This technique was repeated multiple times along different areas of the filter without success.Angioplasty balloon was inflated in an attempt to separate the retrieval hook of the filter from the posterior wall of the vena cava.Attempts to snare the filter were unsuccessful and multiple attempts to retrieve the filter with alligator forceps were performed again without success.Then decision was made to terminate the case.After one month, again the patient scheduled for the filter retrieval, the right jugular and both femoral veins were accessed.Computed tomography (ct) of the abdomen was performed and which showed the tip of the filter perforating the anterior caval wall.Initially an unsuccessful attempt was made to snare the hook using a gunther tulip retrieval system.Second loop-snare was performed to try and capture the filter, and this was also unsuccessful hence a snare and retrieval cone were advanced through the femoral vein sheaths in an attempt to capture the filter however the tip of the filter was firmly embedded, and it only resulted in increased tilting and deformation of the filter.After multiple failed attempts it was decided to stop further attempts.After two weeks, a computed tomography (ct) abdomen and pelvis with contrast was performed and it revealed that the filter was obliquely positioned with respect to the axis of the vena cava with its upper most portion protruding outside of the medial wall of the cava.After two years and six months, a computed tomography angio (cta) chest with contrast was performed and it demonstrated acute pulmonary embolus, and this was seen in the distal aspect of the right main pulmonary artery and it extends into the segmental and distal branches of the right middle lobe arteries.After one week, a computed tomography (ct) abdomen and pelvis with contrast was performed and it revealed that the filter was tilted with the cephalad strut appearing external to the medial wall of the inferior vena cava.This position was likely due to prior attempts at filter retrieval.After four days, the patient scheduled for the filter retrieval, the right internal jugular vein was accessed.An inferior vena cavogram was performed and it revealed that the filter tilted and the hook of the filter in an extravascular position.Endobronchial forceps were initially used to retrieve the filter but were unsuccessful.A loop snare technique using a modified sos omni catheter and stiff angle guidewire was then attempted to free the embedded filter apex.Eventually, endobronchial forceps were able to engage the filter and remove it through the outer 18-french sheath.All 12 tines remained on the filter.Therefore, the investigation is confirmed for the alleged filter tilt, material deformation, 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.Per medical records, multiple attempts were made to engage the apex of the filter using snare and forceps but were unsuccessful due to filter tilt, material deformation and perforation of the inferior vena cava.This could have contributed to the retrieval difficulties.However, 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 in a patient after being diagnosed with deep vein thrombosis and pulmonary embolism.At some time post filter deployment, it was alleged that the filter tilted, tip perforated, deformed and the patient was diagnosed with pulmonary embolism post filter implant.The device has been removed percutaneously after an attempted but unsuccessful percutaneous removal procedure.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: 11820015
• MDR Text Key: 250463222
• Report Number: 2020394-2021-80436
• 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: 05/13/2021

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: 04/19/2021
• Initial Date FDA Received: 05/13/2021
• 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: CLONAZEPAM, CLOZAPINE, DESMOPRESSIN, DOCUSATE; DONEPEZIL HCL, FISH OIL, METOPROLOL TARTRATE; POLYETHYLENE GLYCOL AND TOPIRAMATE
• Patient Outcome(s): Life Threatening
• Patient Age: 58 YR