MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number 26930

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: actual event date is unknown.Event date approximated based on report of event occurring in (b)(6) 2019.

Event Description

It was reported that stent fracture occurred and additional intervention was required.A vici stent was implanted in the right side groin area of a patient.Months later, the patient returned for a procedure on the left side.During a follow up appointment in (b)(6) 2019, two fractures were noted in the stent on patient's right side.A non-boston scientific stent was implanted to cover the fracture.

• 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: 11780652
• MDR Text Key: 249200769
• Report Number: 2134265-2021-05358
• 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: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• 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: 04/08/2021
• 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
• Patient Age: 34 YR