MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SIMON NITINOL FILTER SYSTEM; VENA CAVA FILTER

Model Number	2120F
Medical Device Problem Codes	Malposition of Device (2616); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately one year later, the patient experienced abdominal pain, x-ray of abdomen was performed which revealed there was an inferior vena cava filter noted.After thirteen years and three months, x-ray of spine was performed which showed inferior vena cava filter.After two weeks, computed tomography angiography of chest was performed which showed there was a partially imaged inferior vena cava filter.Findings suspicious for a very small pulmonary embolus to the apical segment of the right upper lobe.After one year and two months, computed tomography of abdomen without contrast was performed which revealed an inferior vena cava filter was in place.The strut at the 7-8 o' clock position perforates beyond the confines of the inferior vena cava by approximately 9 mm extending into the iliopsoas.There was strut perforation of that of the 7 o' clock position by approximately 6 mm.The strut at the 3 o' clock position perforates by approximately 3-4 mm and abuts and minimally indents the abdominal aorta.Strut at the 1 o'clock position barely perforates, perhaps 1 mm or so, and the strut at the 10 o' clock position perforates by approximately 3 mm lying adjacent to the duodenum.There was anterior tilt and minimal lateral tilt of the apex of the filter.The struts are cauded to the renal arteries.The proximal curved portions of the filter well above the struts also perforate slightly with the exception of the curved portion at the 10 o' clock position which perforates by at least 3-4 mm.Therefore, the investigation is confirmed for the alleged filter tilt and perforation of the inferior vena cava.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.Device not returned.
Event or Problem 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, extending despite adequate anticoagulant therapy.At some time, post filter deployment, it was alleged that the filter had perforated and tilted.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: SIMON NITINOL FILTER SYSTEM
• Common Device Name: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12524423
• Report Number: 2020394-2021-01794
• Device Sequence Number: 4306249
• Product Code: DTK
• UDI-Device Identifier: 00801741040900
• UDI-Public: (01)00801741040900
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K970099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2120F
• Device Catalogue Number: 2120F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COUMADIN, PERCOCET AND HEPARIN
• Patient Age: 37 YR