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

Catalog Number EC500F

Device Problems Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2017

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 07/2013).Device not returned.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with extensive left lower extremity deep vein thrombosis and in conjunction before cholecystectomy.Around seven years and seventeen days post filter deployment, a computed tomography (ct) abdomen without oral or intravenous contrast revealed that the filter struts detached, perforated and strut was abnormally positioned.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.

Manufacturer Narrative

H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately seven years later, computed tomography (ct) revealed that there was a bard inferior vena cava filter with its cephalad component just below the level of the right renal vein, the caudad-most vein.No filter migration or tilt were noted.One of the filter arms was located posterior and to the left comes off its central attachment site at an acute angle and penetrated through the wall of the inferior vena cava into the pericaval/mesenteric fat.The abnormal position of this arms suggested that it was bent/fractured.One of the legs of the filter, that was positioned anterior and to the right, cannot be followed continuously from its distal tip to its attachment site of the body of the filter and was likely fractured.Therefore, the investigation is confirmed for alleged filter limb detachment and perforation of the inferior vena cava (ivc) and material deformation.The definitive root cause could not be determined based upon available information.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.H10: d4 (expiry date: 07/2013).H3 other text : device not returned.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with extensive left lower extremity deep vein thrombosis and in conjunction before cholecystectomy.Around seven years and seventeen days post filter deployment, a computed tomography (ct) abdomen without oral or intravenous contrast revealed that the filter struts detached, perforated and strut was abnormally positioned.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
• MDR Report Key: 10820931
• MDR Text Key: 215918637
• Report Number: 2020394-2020-20404
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K093659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EC500F
• Device Lot Number: GFUE4451
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR