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

Model Number	2120F
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	05/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review:the device history record review could not be performed as the lot number is unknown.Investigation summary:the device was not returned for evaluation.Medical records were provided and reviewed.Approximately six years and eleven months of post deployment, computed tomography of abdomen was performed which showed filter was present in expected location 2.7cm below the renal veins.The filter was present centrally in the vein with the superior hook just to left of midline but not abutting the vein wall.No fat stranding or fluid collections surrounding the inferior vena cava which appears normal in caliber.Tines of the inferior vena cava filter extend beyond the wall of the inferior vena cava seen in inferior lateral and inferior medial image.These do not pierce the aorta.No inflammatory changes associated with the large or small bowel.No inflammatory changes or masses in the subcutaneous tissues of the abdomen.Therefore, the investigation is confirmed for perforation of inferior vena cava (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.
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/pulmonary embolism and clotting disorder.At some time post filter deployment, it was alleged that the filter struts perforated the inferior vena cava wall.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient experienced pain in abdomen; however, 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: 12030902
• Report Number: 2020394-2021-80516
• Device Sequence Number: 17334763
• Product Code: DTK
• UDI-Device Identifier: 00801741040900
• UDI-Public: (01)00801741040900
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K970099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2021

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
• 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: 06/08/2021
• Initial Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Weight: 157