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

Catalog Number MD800J

Device Problems Difficult to Remove (1528); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problems Chest Pain (1776); Foreign Body In Patient (2687)

Event Date 03/22/2019

Event Type  Injury  

Manufacturer Narrative

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.Medical records were provided and reviewed.Approximately, two years one month of post deployment, patient presented for the complaints of abdominal pain.Advised to follow-up.Around, two years nine months later, patient presented with the complaints of right upper back pain and chest pain.An ultrasound abdomen was performed for right upper quadrant pain which showed negative study.After, two years three months later, a ventilation perfusion study was performed for shortness of breath.The study showed that no evidence for acute or chronic pulmonary embolism.Around, one month twenty-two days, later, computed tomography angiogram of abdomen and pelvis was performed which showed infra renal inferior vena cava filter with struts extending beyond the inferior vena cava wall.Around, four months and fifteen days later, patient was planned for inferior vena cava filter removal.Scout images demonstrated an intact filter with no broken pieces.This looks like a bard meridian retrievable filter.Bilateral iliac venogram showed absence of clots within the filter nor in the inferior vena cava.Subsequently, a goose neck snare 20 mm loop was used to engage the hook of the filter.The loop was secured around the hook.After advancing the sheath over the filter, a tiny piece of the hook broke of and embolized.Considering it was a tiny piece there was no need to attempt retrieval.Multiple attempts at snaring the neck of that filter were unsuccessful.Proceeded with looping a wire underneath the neck of the filter and pulling it out however despite multiple attempts, we were unsuccessful and some of the tines flipped backwards.In order to avoid a broken piece of the filter and prevent distal embolization, decided to attempt removal using an endobronchial forceps.There was no rigid endobronchial forceps available and decided not to pursue any further attempts.Around, four months and ten days later, patient with high risk for lower extremity thrombosis related to filter and decided to remove.Scout images demonstrated the filter in place however there appears to be 11 legs and arms consistent with fracture of one leg.Upon search for the missing piece, it was found in the right lower lung.Unenhanced cone beam computed tomography was performed, which demonstrated the fractured piece of the filter in the posterior sub segmental right lower lobe pulmonary artery branch.Through the right internal jugular vein access, pigtail catheter passed into left iliac veins.Venogram demonstrated no clots within the inferior vena cava.A rigid endobronchial forceps was advanced through the sheath and filter was grabbed.An inferior vena cava gram demonstrated no complication and no contrast extravasation.On the same day, a computed tomography of chest was performed which showed probable small wire fragment in a sub segmental pulmonary artery in the right lower lobe.A computed tomography of abdomen and pelvis was performed which showed no evidence of competition from inferior vena cava filter removal.Therefore, the investigation is confirmed for the perforation of the inferior vena cava, material deformation, filter limb detachment and retrieval difficulties.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.Expiry date: 10/2012.

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 bent, perforated, detached, migrated to the right lung and patient reportedly experienced chest pain.The device was removed percutaneously after an attempted but unsuccessful percutaneous removal procedure.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: 12662688
• MDR Text Key: 277399544
• Report Number: 2020394-2021-80776
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: GFVI0483
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2021
• Initial Date FDA Received: 10/19/2021
• 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
• Treatment: VITAMIN C, HYDROCODONE AND IBUPROFEN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 95