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); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Of the two devices, one lot number was provided and a lot history review was performed.The devices were not returned to the manufacturer for evaluation; however, medical records were provided for both malfunctions.For both malfunctions, the investigation is confirmed for perforation of inferior vena cava, filter limb detachment and filter tilt.Based upon the available information, the definitive root cause is unknown.The devices are labeled for single use.
Event or Problem Description
A review of the reported information indicated that model 2120f vena cava filter allegedly experienced malposition of device, patient device interaction problem and detachment of device or device component.This information was received from various sources.This malfunction involved all two patients with no consequences.Two patients age were reported ranging from (b)(6) years.One patient was reported as female.All other details of the patients were 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
• MDR Report Key: 12190108
• Report Number: 2020394-2021-80579
• Device Sequence Number: 17041786
• 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: 2
• 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: GFRF3441, 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