MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number 26930

Device Problem Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2020

Event Type  Injury  

Event Description

It was reported that the stent moved within the patient's anatomy.A 16x120x100 vici self-expanding stent was selected for treatment of a may thurner lesion in the common iliac vein (civ).The stent was successfully deployed and appeared fully apposed.Upon removal of the deployment system, the stent moved approximately 100mm within the patient's vessel into the mid-ivc (inferior vena cava) and proximal common iliac vein, leaving the distal tip in the civ.This event required the placement of two additional stents, 18x90 wallstents, to cover the intended location.No patient complications were reported, but the vici remained within the patient.The patient fully recovered and was sent home.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• Manufacturer (Section G): VENITI MANUFACTURING; 4025 clipper ct; fremont CA 94538
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10791106
• MDR Text Key: 214745214
• Report Number: 2134265-2020-15250
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00852725008171
• UDI-Public: 00852725008171
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0020010022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention