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	12/11/2013
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.Post filter deployment, computed tomography of abdomen and pelvis was performed which revealed there was a birds nest type of inferior vena cava filter with its proximal tip roughly 5mm inferior to the left renal vein, the distal prongs do appear to extend minimally beyond the wall of the inferior vena cava but not into adjacent organs.One year and one month later, computed tomography of abdomen was performed which revealed there was an infrarenal inferior vena cava filter, which appears to represent a simon nitinol filter.The top of the filter was below the lowest renal vein by 4.8cm.There was no significant filter tilting.There was a right anterolateral filter leg which is outside of the vena cava wall with 2.5mm of perforation.There was a right posterolateral filter leg which was perforated beyond the inferior vena cava filter wall up to 5mm.Right posterior filter leg was perforated beyond the inferior vena cava wall to 5mm and in the right anterolateral paravertebral space.Left posterior leg was perforated beyond the inferior vena cava wall by 2mm and in the ventral paravertebral space.No definite filter leg fracture or bending.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.At some time post filter deployment, it was alleged that the filter struts perforated into organs and the patient reportedly experienced abdominal pain.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: 12065072
• Report Number: 2020394-2021-80527
• Device Sequence Number: 17334786
• 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
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2021

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: 06/07/2021
• Initial Report FDA Received Date: 06/25/2021
• 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: 48 YR
• Patient Weight: 75