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	03/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a stent migration occurred, requiring new stent placement.Venogram and ivus imaging were performed on an acute deep vein thrombosis (dvt), prior to a stenting procedure.The inferior vena cava (ivc) measured 25mm and the left iliac measured 15.6-18mm.Prior to stenting, thrombectomy and ballooning were performed on the lesion.A 16 x 60mm x 100cm vici self-expanding stent was selected for treatment and was placed in the left iliac/ivc confluence.Upon deployment, the stent fully expanded and apposed the vein walls.The stent was post-dilated.There were no difficulties during the implant procedure and the patient was discharged.The patient returned for a follow-up appointment nine days later, with dvt.It was found that the stent migrated distally, about 4cm.The vici stent was successfully re-stented with a new 18 x 90 wallstent on the right and a 20 x 80 wallstent on the left.The patient is stable and no additional adverse patient effects were reported.Boston scientific (bsc) was only made aware of this event from the physician on april 12, 2021.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 11720489
• Report Number: 2134265-2021-05180
• Device Sequence Number: 17102096
• Product Code: QAN
• UDI-Device Identifier: 00852725008157
• UDI-Public: 00852725008157
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/23/2021

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: 11/30/2022
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0019100036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 92672766-FA
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR