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

Model Number 2120F

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 284020077
• Report Number: 2020394-2022-90036
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040900
• UDI-Public: (01)00801741040900
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Initial Date Manufacturer Received: 12/31/2021
• Initial Date FDA Received: 01/19/2022
• Type of Device Usage: A
• Patient Sequence Number: 1