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

Catalog Number MD800J

Device Problems Extrusion (2934); Patient Device Interaction Problem (4001)

Patient Problem Death (1802)

Event Date 08/24/2016

Event Type  Death  

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: the patient with deep vein thrombosis and a history of pulmonary embolism was contraindicated to anticoagulation; therefore, vena cava filter placement was requested.The right internal jugular vein was accessed and an inferior venacavagram demonstrated no intraluminal thrombus and no vena cava anomaly.The filter was then deployed in the infrarenal vena cava.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.Based on the medical records, the investigation is inconclusive for perforation of vena cava by ivc filter 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.Expiry date: 07/2014; 07/2013.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.At some time post filter deployment, it was alleged that the filter perforated the vena cava.The device has not been removed and there were no reported attempts made to retrieve the filter.Approximately three years eleven months post filter implant, the patient reportedly expired.

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 vena cava.The device has not been removed and there were no reported attempts made to retrieve the filter.Approximately three years eleven months post filter implant, the patient reportedly expired.

Manufacturer Narrative

H10: 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 after two year and three months of post filter deployment a computed tomography showed a grade one perforation and the filter was located on superior to l2-l3 with no migration and filter tilt to found.Therefore, the investigation is confirmed for perforation of ivc.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, d4(expiry date: 07/2014) h11: h6(method, conclusion) h11:section a through f - 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.

• 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
• MDR Report Key: 7558159
• MDR Text Key: 109706025
• Report Number: 2020394-2018-00761
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K102511
• 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: 07/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• 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: GFXF3241
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 89 YR