MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number	26930
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Codes	Dyspnea (1816); Cardiac Tamponade (2226); Device Embedded In Tissue or Plaque (3165); Pericardial Effusion (3271)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent migration occurred via voluntary medwatch mw5096067.A 16x90mm vici self-expanding stent was implanted in the left common and external iliac vein on (b)(6) 2019.In 2020, the patient presented with progressive dyspnea on exertion and imaging found a migrated stent in the right atrium associated a pericardial effusion.Surgery was performed, but only 9cm of the vici stent was able to be removed.The remaining stent was stuck within the inferior vena cava (ivc) wall.Later in 2020, the patient again presented with worsening dyspnea on exertion and a pericardial tamponade requiring pericardiocentesis was found.The patient has effusive-constrictive pericarditis as a result of these procedures.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 10570015
• Report Number: 2134265-2020-13059
• Device Sequence Number: 16930502
• Product Code: QAN
• UDI-Device Identifier: 00852725008164
• UDI-Public: 00852725008164
• Combination Product (Y/N): N
• PMA/510(K) Number: P180013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0019060030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention