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

Catalog Number EC500F

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Material Deformation (2976)

Patient Problem Pain (1994)

Event Date 07/26/2010

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.After, two days of post deployment, an x-ray lumbosacral spine was performed for back pain.The study showed the interval placement of inferior vena cava filter was noted.After, four days, a computed tomography of lumbar spine was performed which showed inferior vena cava filter was noted in malpositioned horizontally within the inferior vena cava.The foot plates may be protruding outside the inferior vena cava lumen.Around, four years and eight months of post deployment, an x-ray abdomen was performed which showed malpositioning of the inferior vena cava filter was noted at the level of l3 was stable.Around, twenty-eight days later, an x-ray abdomen was performed which showed stable malpositioning of an inferior vena cava filter.Around, four months and seventeen days later, an x-ray abdomen was performed which showed inferior vena cava filter was noted at the level of l3-l4.Around, one month and one day alter, on a computed tomography of abdomen and pelvis was performed which showed filter was noted in the inferior vena cava.Around, five months and three days later, an x-ray abdomen was performed which showed inferior vena cava filter was noted malpositioned and has a horizontal tilt.Around, two months and one day later, a computed tomography of pelvis was performed which showed inferior portion of the inferior vena cava filter was noted.Around, one year and one month later, a computed tomography of abdomen and pelvis was performed which showed inferior vena cava filter was noted with abnormal tilt and located essentially sideways in the infrarenal inferior vena cava with one limb projecting close to the aortic wall.One limb arose into the l5 vertebral body series and additional limb extends into the distal duodenum.The apex of the filter may lie outside the right lateral aspect of the inferior vena cava.Around, one month and three days later, a computed tomography of abdomen and pelvis was performed for right and left quadrant intermittent abdominal pain.The study showed that inferior vena cava filter with unchanged abnormal tilt with a horizontal orientation in the infrarenal inferior vena cava and limb erosion of filter.Multiple limbs in close proximity to the aortic wall and l5 vertebral body.Unchanged appearance of single limb in the distal duodenum.Retrieval hook appears extraluminal.Therefore, the investigation is confirmed the perforation of the inferior vena cava (ivc), filter tilt and material deformation.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 in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter tilted and embedded in wall of the inferior vena cava.The device has not been removed and there were no reported attempts made to retrieve the filter.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: 12272081
• MDR Text Key: 264924453
• Report Number: 2020394-2021-80682
• 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: 08/03/2021

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: 07/08/2021
• Initial Date FDA Received: 08/03/2021
• 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: CALCIUM CARBONATE, OMEPRAZOLE AND VITAMIN D; CYCLOSPORIN, CELLCEPT AND MAGNESIUM OXIDE; POTASSIUM CHLORIDE AND FUROSEMIDE; TRAZODONE, LOVENOX AND COUMADIN
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 115