MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number	26930
Medical Device Problem Codes	Human-Device Interface Problem (2949); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that two stents were not visible under fluoroscopy.A 16x120x100 vici self expanding stent and a 14x90x100 vici self expanding stent were selected for a venous iliac stenting procedure.The patient was lying in the prone position and the access point was the left popliteal vein.During the procedure, the physician wanted to land the distal aspect of the 16x120x100 vici self expanding stent right at the confluence.The physician began deployment and was having a difficult time seeing the ro marker and could not see the stent struts at all.Deployment was stopped and instead of using fluoroscopy, the physician used cine acquisition to see the device better.While using cine, it was noted that the stent was 50% deployed in the patient's inferior vena cava (ivc).The stent was pulled down to the proper position and deployment was completed in the left common iliac vein.A 14x90x100 vici self expanding stent was used and the same issues occurred.Cine acquisition was used throughout deployment to make sure the stent was placed in the correct location.The stent was placed in the patient's left external iliac, extending down into the left common femoral.After both stents were deployed, post dilatation was done with a non-bsc balloon catheter.It was confirmed that the stents were apposed to the vessel using ivus.A post procedural angiogram was performed and the end result was great.There were no patient complications and the patient was stable post procedure.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 9413342
• Report Number: 2134265-2019-14950
• Device Sequence Number: 3987625
• Product Code: QAN
• UDI-Device Identifier: 00852725008133
• UDI-Public: 00852725008133
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P180013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2019

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: 02/28/2022
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0019010023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 150