MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number	26930
Date of Event	09/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant date (b)(6) 2020.
Event or Problem Description
It was reported that stent migration occurred.A 16x60x100 vici stent was selected for treatment of may thurner syndrome, in a lesion approximately 20mm long.Initial implant was successful and stent appeared fully apposed in the correct location.Post dilation was performed and post imaging appeared ok.The patient may have been dehydrated at the time of stent implant.A week later, patient presented with chest pain and it was noted that the stent had migrated.The stent was removed successfully and patient was reported as doing fine post removal.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 10733843
• Report Number: 2134265-2020-14718
• Device Sequence Number: 1114169
• Product Code: QAN
• UDI-Device Identifier: 00852725008157
• UDI-Public: 00852725008157
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P180013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/26/2020

1 Device was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0019120018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No