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 10/14/2020

Event Type  Injury  

Event Description

It was reported that the stent migrated.A 14x60 vici stent was selected to treat a may thurner lesion with 87% occlusion in the iliac vein.A venogram and non-boston scientific 0.035 ivus were used to determine vessel size and select stent size.There were no issues upon initial stent placement and the stent was placed in the intended location.Approximately four hours after stent placement, it was noted that the vici stent had migrated to the patient's heart.The stent was snared and pulled back into the inferior vena cava (ivc) and drug back into the iliac vein.A longer, non-boston scientific 14x160 stent was placed inside of the vici stent to secure it into place.No patient complications have been reported and patient was reported as stable and doing well.

• 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: 10791389
• MDR Text Key: 214750212
• Report Number: 2134265-2020-15252
• Device Sequence Number: 1
• Product Code: QAN
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention