MAUDE Adverse Event Report: VENITI, INC. VICI; Stent, iliac vein

Model Number	26930
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	06/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent migrated.A vici self expanding stent was selected for use to treat may-thurner syndrome.On (b)(6), 2020 the stent was implanted in the right iliac vein.The implanted stent reduced the previous swelling in the right lower extremity the patient had experienced.However, the swelling returned at an unspecified time.A transthoracic echocardiogram was performed which revealed that the stent had migrated to the heart and crossed the tricuspid valve and was proximally sitting in the inferior vena cava.The stent was removed via sternotomy on (b)(6), 2021.The tricuspid valve was repaired.The patient was discharged to home on (b)(6), 2021.The post operative course was noted to be uneventful.

• Brand Name: VICI
• Common Device Name: Stent, iliac vein
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15711667
• Report Number: 2124215-2022-43379
• Device Sequence Number: 20488442
• Product Code: QAN
• UDI-Device Identifier: 00852725008157
• UDI-Public: 00852725008157
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P180013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other,Recall
• Type of Report: Initial
• Report Date (Section B): 11/01/2022

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: 10/31/2022
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0019100009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2019
• 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; Life Threatening
• Patient Age: 25 YR
• Patient Sex: Female