MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number 26930

Device Problem Migration (4003)

Patient Problem Swelling/ Edema (4577)

Event Date 05/21/2021

Event Type  Injury  

Event Description

It was reported that stent migration occurred.A vici 14x120 self-expanding stent was implanted in the left common iliac vein of a patient on (b)(6) 2020 to treat left leg swelling and claudication.It was reported that the swelling did not go down, so the physician requested the patient come in for a follow up.On (b)(6) 2021, it was noted that the vici stent had migrated to the inferior vena cava (ivc) just below the heart.An attempt was made to snare the vici stent, ivus was performed and under fluoroscopy it was seen that the entire ivc was pulling during the snare attempt.The physician believed that the stent likely migrated early on post-implant.The vici stent was unable to be removed and will be left as-is and monitored by physician.The patient was put on anticoagulants and will continue to be monitored by the physician.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• Manufacturer (Section G): VENITI, INC.; 4025 clipper court; fremont CA 94538
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12006108
• MDR Text Key: 256449519
• Report Number: 2134265-2021-07746
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• 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
• Date Manufacturer Received: 05/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: 92672766-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 59 YR