MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number 26930

Device Problems Nonstandard Device (1420); Migration (4003)

Patient Problems Nerve Damage (1979); Paralysis (1997)

Event Date 03/22/2021

Event Type  Injury  

Manufacturer Narrative

Implant date: it was reported that the stent was implanted on (b)(6) 2021, which is a day after the event date.

Event Description

It was reported via voluntary medwatch/maude report list # mw5103609 that stent migration occurred.A vici stent was implanted.Surgery was performed, and the stent migrated.The stent ended up in the patient's heart, which resulted in open heart surgery.The patient reported this affected the nerves in the left leg leading to paralysis.The patient has been in a nursing home for three months since the incident.

• 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: 12720669
• MDR Text Key: 279227447
• Report Number: 2134265-2021-13453
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• 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
• Date Manufacturer Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 92672766-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention