MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number 26930

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 05/12/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: patient was in 20s.

Event Description

It was reported that stent fracture occurred.During a routine follow up procedure, patient presented with a pinching sensation in hip.After a computed tomography (ct) scan was performed, the physician suspected the vici self expanding stent previously implanted, had fractured.The fracture is thought to be in the center of the stent at the outer inflection point.At this time, no additional intervention was done nor have any future procedures been scheduled.The physician is monitoring the patient and may do diagnostic intervention to assess if symptoms continue or get worse.

• 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: 10092121
• MDR Text Key: 193112588
• Report Number: 2134265-2020-07001
• 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: 05/27/2020

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: 05/12/2020
• Initial Date FDA Received: 05/27/2020
• 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): Other