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)

Patient Problems Abdominal Pain (1685); Thrombosis/Thrombus (4440)

Event Date 11/19/2015

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.Bard eclipse filter was deployed in the inferior vena cava via the femoral route for a patient with a history of deep vein thrombosis.Approximately one year and seven months of post deployment, the patient presented to the hospital for abdominal and pelvic pain.The patient underwent a computed tomography of the abdomen and pelvis, and it displayed both above (non-occlusive) and below (occlusive) inferior vena cava filter thrombosis extending to the bilateral iliac and femoral veins, and bilateral lower extremity deep vein thrombosis.The next day, a left common iliac vein wallstent 14 millimeters by 60 millimeters and 14 millimeters by 40 millimeters with post dilation with atlas balloon 14 millimeters by 40 millimeters was placed.The right superficial femoral vein, common femoral vein, external iliac vein, common iliac vein, and inflow into the inferior vena cava was widely patent.The inferior vena caca was widely patent with the inferior vena cava filter without significant thrombus noted.The left common femoral and external iliac veins were widely patent.The common iliac vein had significant stenosis with a large gonadal vein identified.There was a small cuff of patient left common iliac vein distal to the stenosis.Following balloon angioplasty and stenting of the common iliac vein, no residual stenosis was noted.Around two months later, an attempt to retrieve the inferior cava filter was made.Multiple attempts to snare the hook of the filter were made.The hook of the filter appeared to be embedded in the inferior vena cava and the filter was tilted, and the procedure was unsuccessful.A 16 millimeter by 40 millimeters atlas balloon was used to balloon the vena cava near the filter to try to disengage the above the filter from the inferior vena cava.This was yet another failed attempt.After multiple attempts, catheter was placed down below the inferior vena cava and the inferior vena cavogram was obtained which showed the cava to be patent and there was no extravasation.The filter was not retrieved, but the patient tolerated the procedure well.Around three years and nine months later, a computed tomography of the abdomen and pelvis was performed.The inferior vena cava filter was positioned with the tip just below the level of the right renal vein.The tip was deviated anteriorly with the tip opposing the ventral wall of the inferior vena cava.There were 12 filter struts inferiorly.Approximately 10 of the struts extended beyond the wall of the inferior vena cava.One of the struts was deviated approximately 9 millimeters beyond the wall and abuts the right posterior aspect of the aorta without perforation.Another strut opposed the ventral aspect of the lumbar spine.The struts appeared intact.The left common iliac vein stent was in place.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc), filter tilt and retrieval difficulties.Per medical records, multiple attempts were made to engage the apex of the filter but were unsuccessful due to filter tilt and perforation of inferior vena cava (ivc).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.(expiry date: 02/2017).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter tilted and struts perforated beyond the wall of the inferior vena cava.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.The patient experienced abdominal pain and thrombosis.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: 12317410
• MDR Text Key: 266360404
• Report Number: 2020394-2021-80699
• 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: 08/13/2021

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: GFYA2843
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2014
• 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: GABAPENTIN, MELOXICAM, TIZANIDINE; MACROBID, MAXITROL, METOPROLOL; SEROQUEL, MOXIFLOXACIN, PREDNISOLONE
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Weight: 108