MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number	26930
Medical Device Problem Codes	Positioning Failure (1158); Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was stuck on the guidewire.A 16x120mm, 100cm vici self expanding stent was selected for use in a stenting procedure within the left iliofemoral veins.The patient had a tumor that was causing compression.During the procedure, the stent would not deploy.The tuohy was loosened to deploy the vici stent, but the vici stent catheter would not move.The vici stent catheter was stuck and could not be pulled back.The vici stent catheter was removed.The procedure was completed with a 14x120mm, 100cm vici self expanding stent.No patient complications were reported.
Event or Problem Description
It was reported that the device was stuck on the guidewire.A 16x120mm, 100cm vici self expanding stent was selected for use in a stenting procedure within the left iliofemoral veins.The patient had a tumor that was causing compression.During the procedure, the stent would not deploy.The tuohy was loosened to deploy the vici stent, but the vici stent catheter would not move.The vici stent catheter was stuck and could not be pulled back.The vici stent catheter was removed.The procedure was completed with a 14x120mm, 100cm vici self expanding stent.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: the device was received with the stent partially deployed on the delivery system.The distal stent wires were found to be damaged.This type of damage could potentially have occurred due to excessive force being applied to the device when attempting to deploy the stent in challenging patient anatomy.The investigator successfully deployed the stent with some resistance experienced due to a severe kink to the shaft and solidified media inside the delivery system.No damage or issues were noted with the deployed stent.A visual and tactile inspection identified a severe kink on shaft of the device located approximately 15mm distal of the mail valve.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination identified no issues with the tip of the device.No other issues were identified during the product analysis.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 11267029
• Report Number: 2134265-2021-01073
• Device Sequence Number: 3256566
• Product Code: QAN
• UDI-Device Identifier: 00852725008171
• UDI-Public: 00852725008171
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/08/2021

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: 07/31/2022
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0019060035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 03/08/2021
• Patient Sequence Number: 1