MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number 26930

Device Problem Material Deformation (2976)

Patient Problem Thrombosis (2100)

Event Date 10/29/2019

Event Type  Injury  

Event Description

It was reported that the stent became occluded and stent damage occurred.The lesion was located in the common iliac vein.Two vici self expanding stents were selected for treatment and were placed.During the procedure, the 16x90x100 vici stent clotted off during the procedure.The patient was put on thrombolysis overnight.The next day, the clot was still there and the physician used a penumbra device to remove the clot.After the use of the penumbra, it was noted that the distal end of the external iliac stent was compressed and foreshortened.The physician used a balloon to open and stretch the stent.A wallstent was placed to open and extend the foreshortened stent.There were no patient complications reported.

Event Description

It was reported that the stent became occluded and stent damage occurred.The lesion was located in the common iliac vein.Two vici self expanding stents were selected for treatment and were placed.During the procedure, the 16x90x100 vici stent clotted off during the procedure.The patient was put on thrombolysis overnight.The next day, the clot was still there and the physician used a penumbra device to remove the clot.After the use of the penumbra, it was noted that the distal end of the external iliac stent was compressed and foreshortened.The physician used a balloon to open and stretch the stent.A wallstent was placed to open and extend the foreshortened stent.There were no patient complications reported.Additional information reported that the length of the lesion was approximately 160 cm.The area was not pre-dilated prior to stenting.Inflow was confirmed post-stenting.There were no comorbidities indicated.The physician thinks that use of penumbra to remove the clot after stent deployment caused the stent foreshortening.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 9365381
• MDR Text Key: 167757753
• Report Number: 2134265-2019-14203
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): N
• PMA/PMN Number: P180013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PENUMBRA DEVICE; PENUMBRA DEVICE
• Patient Outcome(s): Required Intervention