MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number	26930
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent migration occurred.A 14x60mm, 100cm vici stent system was selected for use.Following pre-dilation, the vici stent was deployed in the proximal left iliac vein.Under fluoroscopy, a balloon was inserted for post-dilation.However, it was noticed that the stent had migrated to the inferior vena cava (ivc).When attempting to insert the balloon further, the stent then migrated further up the ivc until it reached the right atrium of the heart.A snare was used to retrieve the stent and remove it from the patient.A new vici stent of the same size was then deployed in the target lesion with no difficulties.The procedure was completed and the patient did well.Boston scientific (bsc) was only made aware of this event from the physician on april 12, 2021.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 11717211
• Report Number: 2134265-2021-05149
• Device Sequence Number: 3833465
• Product Code: QAN
• UDI-Device Identifier: 00852725008126
• UDI-Public: 00852725008126
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/23/2021

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: 06/30/2023
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0020050022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 04/23/2021
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 92672766-FA
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR