MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number 26930

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2021

Event Type  Injury  

Manufacturer Narrative

Event date approximated to (b)(6) 2021 based on the date bsc was made aware of this event.Implant date: sometime in 2020.

Event Description

It was reported that stent migration occurred.An unknown sized vici stent was placed in a patient in 2020.The stent was noted to have migrated to the tricuspid.

Event Description

It was reported that stent migration occurred.An unknown sized vici stent was placed in a patient in 2020.The stent was noted to have migrated to the tricuspid.It was further reported that a 16x60x100 vici self-expanding stent was implanted via the right femoral vein to treat patient with chronic right leg swelling.Right common femoral vein (cfv) was accessed and right iliac vein and inferior vena cava (ivc) were noted as unremarkable.Per ivus, it was indicated there was significant narrowing at the central common iliac vein (civ).The vici stent was used to treat the area of compression.Stent was post dilated using a 12x40 unknown balloon and then a 14x40 non-boston scientific balloon, showing a good venographic and ivus result.The vici stent was reported to have migrated to the patient's pulmonary valve.The valve was reconstructed and patient was reported to be doing well.

Manufacturer Narrative

B3: date of event: event date approximated to (b)(6) 2021 based on the date bsc was made aware of this event.D6a: implant date: sometime in 2020.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 12225544
• MDR Text Key: 263462686
• Report Number: 2134265-2021-09354
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): N
• PMA/PMN Number: P180013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0019100009
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/26/2021
• Supplement Dates Manufacturer Received: 08/09/2021
• Supplement Dates FDA Received: 08/27/2021
• Removal/Correction Number: 92672766-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 20 YR