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

Catalog Number EC500J

Device Problems Malposition of Device (2616); Extrusion (2934)

Patient Problems Abdominal Pain (1685); Hematoma (1884); Great Vessel Perforation (2152)

Event Date 10/01/2011

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.This is the only event reported to date for this lot number and failure mode.Medical records review: the patient with bilateral pulmonary embolism and a right lower extremity deep vein thrombosis had a vena cava filter successfully deployed infrarenally.A post-deployment inferior venacavogram demonstrated the filter to be in good position.The patient tolerated the procedure well and was in stable condition at the conclusion of the procedure.Five days post filter deployment, the patient presented to the emergency department complaining of pain in the back and abdomen and an increasing abdominal girth.Ct revealed retroperitoneal and retroaortic hematomas.It was noted that the acute retroperitoneal bleed was most likely related to perforation of the inferior vena cava from the filter and that one filter limb was out of the vein posterior to aorta with a hematoma behind the aorta extending into the psoas.During scheduled retrieval, an inferior venacavogram demonstrated the filter significantly tilted with multiple limbs protruding through the ivc wall.The filter was captured with a snare and removed in its entirety.A new filter (other manufacturer) was advanced and deployed.A post deployment inferior venacavogram demonstrated no evidence for caval disruption or significant complication.The patient tolerated the procedure well without any immediate complications and discharged on hospital day three in stable condition.Follow-up ct scans demonstrated reduction in the size of the hematomas and complete resolution of the retroperitoneal hematoma.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.Based on the medical records, the investigation can be confirmed for tilted filter and the perforation of the ivc.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings/potential complications: movement, migration or tilt of the filter are known complications of vena cava filters.Perforation or other acute or chronic damage of the ivc wall filter tilt.Filter malposition.Note: it is possible that complications such as those described in the "warnings", "precautions", or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

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 perforated the vena cava wall.The filter was removed percutaneously.The status of the patient is unknown.

• Brand Name: ECLIPSE FILTER SYSTEM - JUGULAR
• 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7308424
• MDR Text Key: 101341393
• Report Number: 2020394-2018-00181
• 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: Attorney
• Type of Report: Initial
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2014
• Device Catalogue Number: EC500J
• Device Lot Number: GFVF4078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2011
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 87