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

Catalog Number EC500F

Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problems Extravasation (1842); Hemorrhage/Bleeding (1888)

Event Date 04/11/2010

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 not provided.Therefore, the investigation is inconclusive for filter tilt, perforation of the ivc and filter limb detachment as no objective evidence has been provided to confirm any alleged deficiency with the filter.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.(expiry date: 01/2013).

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 and in conjunction with or before bariatric procedure.At some time post filter deployment, it was alleged that filter tilted and embedded in the wall of the ivc; struts were detached and perforated outside the ivc and bleeding.The device was removed percutaneously.It was further reported that the detached strut retained in neck.The patient experienced retroperitoneal hemorrhage; however, the current status of the patient is unknown.

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, in conjunction with or before bariatric procedure.At some time post filter deployment, it was alleged that filter tilted and embedded in the wall of the ivc; struts were detached and retained in neck and perforated outside the ivc and bleeding.The device was removed percutaneously.The patient experienced retroperitoneal hemorrhage; however, the current status of the patient is unknown.

Manufacturer Narrative

H10: 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.After one month and six days of post filter deployment, computed tomography (ct) scanning was revealed that inflammation and blood along the right side of the inferior vena cava filter which was placed over l2, had migrated down to l4 with a couple of the legs outside the vena cava with some retroperitoneal bleeding.Subsequent impression from ct was revealed the tilt of the filter and two or three of the tines were outside of the inferior vena cava.One day later, on 12-apr-2010 an retrieval attempt was made with the right internal jugular vein with bard retrievable device, but it was not successful the retrieval was very difficult.An second attempt made with variety of sizes of gooseneck snares and an ensnare but still not able to retrieve the filter.The filter appeared to be embedded in the wall.The left common femoral vein was cannulated, the filter was retrieved entirely.Therefore, the investigation is confirmed for perforation of the ivc, filter migration, filter tilt and retrieval difficulties.However, the investigation is inconclusive for filter limb detachment.Per medical records, multiple attempts were made to engage the filter using snare but were unsuccessful due to filter tilt and embedment.This could have contributed to the retrieval difficulties.However, the definitive root cause is unknown.Labeling review: instructions for use: warnings: the safety and effectiveness of this device has not been established for morbidly obese patients.Open abdominal procedures such as bariatric surgery may affect the integrity and stability of the filter 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.

• 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: 9610225
• MDR Text Key: 175923829
• Report Number: 2020394-2020-00658
• 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: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• 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: GFUA1299
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COUMADIN, GLUCOPHAGE, PAXIL, FERROUS SULPHATE; FENTANYL PATCH, ROXICET
• Patient Outcome(s): Other
• Patient Age: 23 YR