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	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided for 2 out of 6 malfunctions, therefore, lot history reviews were performed.Product catalog number for the three reported malfunctions were reported as unknown snf.The devices were not returned to the manufacturer for evaluation; however, medical records were provided and reviewed for all the six malfunctions.Images were provided and reviewed for two malfunctions.All the six reported malfunctions were confirmed for the alleged filter perforation.Based on the available information, the definitive root cause is unknown.The devices were labeled for single use.
Event or Problem Description
A review of the reported information indicated that model 2120f vena cava filter allegedly experience perforation.The information was received from various sources.All the six malfunctions were involved patients with no reported consequences.Of the reported six patients, two male patients ages were ranged from 48 to 69 years old and four female patients ages were ranged from 64 and 79 years old.Weight of two patients were ranged between 106 to 235 kgs; however, remaining patients weight were 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: 12193913
• Report Number: 2020394-2021-80594
• Device Sequence Number: 3397775
• 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: 6
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2021

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: No Information
• Device Model Number: 2120F
• Device Catalogue Number: 2120F
• Device Lot Number: GFSH3235,GFUF2963,UNKNOWN
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/19/2021
• Patient Sequence Number: 1