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); Patient Device Interaction Problem (4001)

Patient Problem Chest Pain (1776)

Event Date 07/22/2017

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.Approximately seven years and five months post filter deployment, filter explant was performed.The filter had a slight tilt to it.Through the 9 french retrieval sheath, the filter able to be snared and removed without difficulty.A count of number of filter legs before and after removal was done.All 12 legs were present and were intact.Therefore, the investigation is inconclusive for perforation of the inferior vena cava (ivc) and filter tilt.Based on the provided medical records, there is no clear evidence to confirm for filter tilt as it reported that, ¿the filter had a slight tilt to it.¿ 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 filter tilted and perforated.The device was removed.The patient reportedly experienced chest pain where the filter was placed; however, the current status of the patient is unknown.

Manufacturer Narrative

H10: 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.Approximately six years and two months later post filter deployment, computed tomography of abdomen and pelvis with oral and intravenous contrast showed that there was an eclipse inferior vena cava filter in place.The retrieval hook was positioned 3 cm inferior to the right renal vein.The filter appeared intact without evidence of fracture.There was 6-degree mediolateral tilt of the filter with the tip to the right.There is 90-degree anteroposterior tilt of the filter with the tip pointing posteriorly.The filter did not appear to be embedded in the inferior vena cava wall.Multiple filter struts appeared outside the inferior vena cava wall representing perforation.There was at least grade 2 perforation of multiple struts and probable grade 3 perforation of at least one or more filter strut.After one year and two months, filter explant procedure was performed.Access was gained via the right internal jugular vein.The filter had a slight tilt to it.Through the 9-french retrieval sheath, the snare catheter was brought down together with the snare.It was possible to place the snare over the area of the filter hook.However, it was clear that there was some fibrosis there because the snare would come off easily.However, it was carefully done such that the snare would cinch down right on the area of the hook, and it was possible to snare the filter without difficulty.A count of number of filter legs before and after removal was done.All 12 legs were present and were intact.Therefore, the investigation is confirmed for the alleged filter tilt and perforation of the inferior vena cava.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.H10: b6, b7, g3.H11: b3, h6 (result).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 filter tilted and perforated the vena cava.The device was removed.The patient reportedly experienced chest pain where the filter was placed; however, 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: 10512896
• MDR Text Key: 206288015
• Report Number: 2020394-2020-05602
• 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,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 122 KG