MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number	26930
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	09/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via voluntary medwatch/ maude report list # mw5106402 that the stent occluded and fractured.In 2020, a 16mm x 120mm, 100cm vici stent was implanted in the left external iliac.In 2021, a venogram revealed that the stent occluded.Thrombectomy was performed to treat the occlusion.A stent fracture was observed, and a non-boston scientific stent was implanted.
Additional Manufacturer Narrative
Initial reporter name: reported by patient.

• 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: 13586341
• Report Number: 2134265-2022-01835
• Device Sequence Number: 4368649
• Product Code: QAN
• UDI-Device Identifier: 00852725008171
• UDI-Public: 00852725008171
• Combination Product (Y/N): N
• PMA/510(K) Number: P180013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/13/2022
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0019120020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown