MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number	26930
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that stent migration occurred.A 16 x 60mm x 100cm vici self-expanding stent was selected for use in the right iliac vein.A venogram and intravascular ultrasound (ivus) were used to image the lesion prior to stent implantation.There was no significant lesion or obstruction present, and the physician opted to stent based on symptoms alone.The reference vessel was 14mm and the stent was upsized by 2 mm.The stent was implanted without any difficulties and a balloon was used for post-dilation.Upon deployment, ivus was performed showing a well apposed stent and patent lumen.However, on the same day, after the patient was discharged, the stent migrated to the heart.The patient condition was stable, and the patient returned to the hospital where intervention was performed.The stent was retrieved and removed from the heart.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.
Event or Problem Description
It was reported that stent migration occurred.A 16 x 60mm x 100cm vici self-expanding stent was selected for use in the right iliac vein.A venogram and intravascular ultrasound (ivus) were used to image the lesion prior to stent implantation.There was no significant lesion or obstruction present, and the physician opted to stent based on symptoms alone.The reference vessel was 14mm and the stent was upsized by 2 mm.The stent was implanted without any difficulties and a balloon was used for post-dilation.Upon deployment, ivus was performed showing a well apposed stent and patent lumen.However, on the same day, after the patient was discharged, the stent migrated to the heart.The patient condition was stable, and the patient returned to the hospital where intervention was performed.The stent was retrieved and removed from the heart.It was further reported that the patient was treated due to symptomatic may-thurner on the left side.There was approximately an 85% focal compression on the left side.A vici stent was placed with no issues.A 16x60mm stent was also placed on the right side based on the patient symptoms.There was no compression and no identifiable lesion to treat.The landing zones were measured via ivus to be approximately 14mm.The 16x60 vici stent placed on the right side landed well below the ivc-civ confluence and entirely in the iliac vein.Both vici stents expanded as expected and were post-dilated with a balloon.Post-discharge (same day), the patient was readmitted and transferred to another hospital as the stent from the right iliac had migrated to the heart.The stent was removed from the heart.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 10569995
• Report Number: 2134265-2020-13051
• Device Sequence Number: 19619549
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2020

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: 03/31/2023
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0020030006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 10/21/2020
• 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: Required Intervention