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

Catalog Number EC500J

Device Problems Patient-Device Incompatibility (2682); Extrusion (2934)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.The device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for perforation of the ivc as no objective evidence has been provided to confirm any alleged deficiency with the filter.Based upon 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.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 sometime post filter deployment, the patient allegedly has multiple struts perforating the inferior vena cava into the space between the vena cava and abdominal aorta.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 review is not required.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately, six years seven months of post deployment, computed tomography of the abdomen was revealed the filter was in appropriate location and shows no evidence of tilt.A posterior single strut extends 3 mm peripheral to the inferior vena cava wall.A medial strut was seen in the fat between the aorta and inferior vena cava but did not extend 3 mm peripheral to the inferior vena cava wall.Therefore, the investigation is confirmed for the perforation of the inferior vena cava (ivc).Based upon 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.H10: b5,d4(expiry date: 06/2013),g2,g3.H11: d1,d4,d6(date of implant),g1,h6(device,method, conclusion).H11:section a through f - the information provided by bd 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 bd.

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 struts perforated the inferior vena cava into the space between the vena cava and abdominal aorta.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 - JUGULAR
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7661223
• MDR Text Key: 113169021
• Report Number: 2020394-2018-01105
• 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: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EC500J
• Device Lot Number: GFUE4468
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LISINOPRIL, AND HYDROCHLOROTHIAZIDE; NEXIUM, SYNTHROID, COUMADIN
• Patient Age: 60 YR