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); Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation; however, medical records were provided and reviewed.Therefore, the investigation is confirmed for deployment issue, material deformation, positioning issue and perforation.However, the investigation is inconclusive for tilt.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
Event or Problem Description
A review of the reported information indicates that model 2120f vena cava filter allegedly experienced malposition of device, perforation, deployment issue, material deformation and positioning problem.The information was received from a single source.This malfunction involved one patient with no patient consequences.A (b)(6) old male patients weight was not provided.

• 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
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13287948
• Report Number: 2020394-2022-90036
• Device Sequence Number: 4554950
• Product Code: DTK
• UDI-Device Identifier: 00801741040900
• UDI-Public: (01)00801741040900
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/19/2022

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
• Device Model Number: 2120F
• Device Catalogue Number: 2120F
• Device Lot Number: GFRF4639
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2021
• Initial Report FDA Received Date: 01/19/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown