MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number 26930

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2019

Event Type  Injury  

Event 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
• Manufacturer (Section G): VENITI, INC.; 4025 clipper court; fremont CA 94538
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9328302
• MDR Text Key: 166585680
• Report Number: 2134265-2019-13869
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00852725008164
• UDI-Public: 00852725008164
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0019060030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR