MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number	26930
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent migration occurred.A 4mmx120mmx100cm vici self-expanding stent was selected for to treat venous compression (nivl).The stent was placed in the proximal common iliac vein (civ) to the mid-external iliac vein (eiv) on (b)(6) 2021.Prior to implant, imaging was performed via ivus and venogram and the stent was selected based on the measurements gathered.Post implant, the stent was ballooned and it was reported to be fully expanded and apposed to the vessel walls.When patient returned to the health care facility on (b)(6) 2021 for an additional procedure, it was noted that the stent had migrated to the inferior vena cava (ivc).The stent was not repositioned or removed.No patient complications were reported, and the patient is doing well.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 11813171
• Report Number: 2134265-2021-06146
• Device Sequence Number: 16956269
• Product Code: QAN
• UDI-Device Identifier: 00852725008140
• UDI-Public: 00852725008140
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P180013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 05/12/2021

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: 11/30/2023
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0020110025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/12/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WALLSTENT 18X90X75
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR