MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number	26930
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was foreign material in the device.A 16mm x 90mm x 100cm vici stent system was selected for use in an iliac vein stenting procedure.During preparation, the stent was flushed, and blue lint-like particles were continuously flushed out of it.The procedure was completed with a new stent.No patient complications were reported, and the patient had a good outcome.
Event or Problem Description
It was reported that there was foreign material in the device.A 16mm x 90mm x 100cm vici stent system was selected for use in an iliac vein stenting procedure.During preparation, the stent was flushed, and blue lint-like particles were continuously flushed out of it.The procedure was completed with a new stent.No patient complications were reported, and the patient had a good outcome.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was received with the stent fully constrained in the correct position the delivery system.A visual and tactile inspection identified no kinks or damage to the delivery system of the device.The investigator attached a syringe to both the flushing port and guidewire port of the device and successfully flushed both the device and the guidewire lumen without issue.No foreign material (fm) was identified exiting from any part of the device when flushed.A visual and tactile examination found the stainless-steel shaft of the device to be severely kinked at the center.This type of damage is consistent with excessive force being applied to the device.A visual and tactile examination identified no issues with the tip of the device.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 11409002
• Report Number: 2134265-2021-02692
• Device Sequence Number: 4076583
• Product Code: QAN
• UDI-Device Identifier: 00852725008164
• UDI-Public: 00852725008164
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P180013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021

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: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0020080043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1