MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number	26930
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Ulcer (2274); Swelling/ Edema (4577)
Date of Event	01/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stents migrated.On (b)(6) 2019, a 14mm x 90mm x 100cm and a 14mm x 120mm x 100cm vici self-expanding stents were implanted in the bilateral iliac vein for treatment of may-thurner syndrome at the osteum.The stents were kissing at the inferior vena cava.The 120mm stent was placed within the target lesion, and both stents covered well.On (b)(6) 2021, the patient presented with symptoms representative of deep venous disease, which included ulcerations, edema, and a lack of relief from the original symptoms after the first procedure.Upon doing a follow-up venogram, the stents presented side-by-side in the mid upper vena cava, which was higher than the confluence.It was unclear if the stents migrated peri-operatively during the previous intervention on (b)(6) 2019, or if they migrated post operatively.The stents were stable.The procedure was resolved by placing two non-overlapping self-expanding wallstents in the iliac.No other patient complications were reported.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 11279389
• Report Number: 2134265-2021-01239
• Device Sequence Number: 19505185
• Product Code: QAN
• UDI-Device Identifier: 00852725008133
• UDI-Public: 00852725008133
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P180013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2021

1 Device was Involved in the Event

1 Patient 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: 08/31/2022
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0019080062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 02/04/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR