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

Catalog Number MD800J

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Migration (4003)

Patient Problem Abdominal Pain (1685)

Event Date 11/19/2018

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.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately, two years and four days of post deployment, a computed tomography abdomen and pelvis was performed on patient reportedly experiencing abdominal pain.Findings noted minimal pleural effusions were present bilaterally and minimal infiltration posterior basilar region.Filter in the infra renal inferior vena cava was noted.Around, four years and four months later, a standard computed tomography was performed, demonstrating positive evidence of caval perforation with 9 o¿clock inferior strut of grade 2 perforation measuring at 3.7mm, 7 o¿clock inferior strut perforation measuring 3.6mm, and proximal struts with a grade 1 relation to the caval wall consistent with tenting.Filter was noted with posterior tilt measuring 17.66 degrees, 6-degree tilt to the left on the coronal images and a 6-degree tilt anteriorly on the sagittal images.All the struts of the filter protruded through the walls of the inferior vena cava into the surrounding adjacent tissues consistent with grade 2 perforations of the majority of the struts.The 2 anterior struts abutted the posterior wall of the duodenum, suggesting grade 2 or possibly grade 3 perforations.No involvement of the aorta was appreciated.Evidence of migration was also noted with the superior tip of the inferior vena cava was at the level of the renal veins.The upper tip of the filter ended at the upper level just below the level of the renal veins.No obvious clot is seen within the inferior vena cava without contrast.Therefore, the investigation is confirmed for the perforation of the inferior vena cava (ivc), filter tilt and filter migration.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: 02/2013).

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.At some time post filter deployment, it was alleged that the filter perforated the inferior vena cava.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: MERIDIAN 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 ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12382013
• MDR Text Key: 268629352
• Report Number: 2020394-2021-80708
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102511
• 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
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MD800J
• Device Lot Number: GFWA4190
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2012
• 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
• Treatment: BUSPIRONE, AMITRIPTYLINE, IMITREX, FLUOXETINE; COUMADIN, LORTAB, CIPROFLOXACIN-CIPROFLOX HCL; CYANOCOBALAMIN, AND WARFARIN; HYDROCODONE, FIORICET, TOPAMAX, GEODON
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 94