MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number	26930
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent was difficult to place and it moved requiring additional intervention.A 60x90x100 vici self expanding stent was selected for an iliac venous stenting procedure in the left side common iliac vein (civ) proximal.The lesion was 50mm in the reference vein measuring 14.75mm distal and 15.5mm proximal.Access was obtained through the left common femoral vein (lcfv).Deployment was initiated, but the stent was repositioned to deploy at the bifurcation.The stent was precisely placed right at the bifurcation and covered the compression.The stent was interrogated under ivus and it was found to not be providing the outward radial force necessary to improve outflow.The stent under fluoroscopy showed a shift downward about 1.5-2cm back into the lciv, below the compression.This was not where the physician intended to release the stent.Deployment was difficult due to the delivery system.It was difficult to slide to release the stent.Post dilatation was done with a 16mmx4mm balloon at 5atm.A secondary stent was placed to improve the landing zone outflow as well as to provide optimal radial strength.The stent was implanted with no harm to the patient.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 9328302
• Report Number: 2134265-2019-13869
• Device Sequence Number: 11250625
• Product Code: QAN
• UDI-Device Identifier: 00852725008164
• UDI-Public: 00852725008164
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P180013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2019

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 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: 10/30/2019
• Initial Report FDA Received Date: 11/15/2019
• 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
• Patient Age: 56 YR