MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number	26930
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that inaccurate stent placement occurred resulting in additional stenting.The target lesion was located in the common iliac vein.A 16x60mm vici stent was selected and inserted via a jugular approach.The delivery system was advanced within the common iliac vein and the physician positioned the marker bands according to lesion's length.The stent was deployed and the stent's expansion was shorter than the length that was visualized when sheathed in the delivery system.The deployed length was shorter by 3-4mm.This resulted in the lesion not being fully treated.Subsequently, additional stenting was required using another non-bsc stent to fully cover the lesion.No patient complications were reported and the patient's status post procedure was fine.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 8692395
• Report Number: 2134265-2019-06503
• Device Sequence Number: 11413180
• Product Code: QAN
• UDI-Device Identifier: 00852725008157
• UDI-Public: 00852725008157
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 06/12/2019

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: 11/30/2021
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0018100010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention