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

Catalog Number MD800J

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Extrusion (2934)

Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685); Chest Pain (1776)

Event Date 06/25/2013

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: this patient with deep vein thrombosis (dvt) and pulmonary embolism (pe) had a vena cava filter deployed in the suprarenal inferior vena cava (ivc) due to a mega cava.Post deployment cavogram demonstrated adequate alignment of the filter with the caval lumen and some extra distribution of the filter legs.Approximately one year and four months post filter deployment, the patient had stopped anticoagulation, was admitted to the hospital for chest pain and found to have evidence of pe along with dvt.The patient was started on anticoagulation and discharged four days later.Approximately five years and six months post filter deployment, an ultrasound of the abdomen demonstrated retroperitoneal varices.Approximately one month later, the patient was evaluated for filter removal for abdominal pain.The physician reviewed a computed tomography scan of the abdomen and indicated that the filter appeared to have a strut exiting the ivc at the level of the liver.The patient was scheduled for retrieval of the filter and the filter was retrieved with difficulty using a snare sheath combination.The filter was inspected and all the struts appeared to be present without any breakage.The post-removal venogram showed no extravasation of contrast.The patient tolerated the procedure well.There were no complications.Investigation summary: the device was not returned for evaluation and images were not provided for review.However, medical records were provided and reviewed.Based on the medical records, it can be confirmed the patient experienced pe after filter implantation; however, the origin and relationship to the filter has not been established in the provided medical records.Additionally, the investigation can be confirmed for perforation of the ivc wall and difficulties removing the filter.The investigation is inconclusive for a tilted 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.Expiry date: 12/2012; 12/2011.- 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 and due to right heart strain.At some time post filter deployment, it was alleged that the filter perforated organs, tilted and embedded.The device was removed percutaneously.Reportedly, the patient experienced pulmonary embolism and deep vein thrombosis post filter implant; however, the 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7546660
• MDR Text Key: 109361333
• Report Number: 2020394-2018-00740
• 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: Attorney
• Type of Report: Initial
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• 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: GFVL0145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2018
• 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): Hospitalization; Life Threatening
• Patient Age: 52 YR
• Patient Weight: 166