MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number	26930
Medical Device Problem Codes	Break (1069); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hypotube broke.A 16x120mm, 100cm vici stent was selected to treat a lesion in the right external iliac common femoral vein.A 9f sheath was placed and a 0.035 guidewire was advanced to the lesion.Then the vici stent was introduced and deployment was initiated.The tuohy was loosened and the physician pinned the inner shaft and started to pull the outer shaft of the delivery catheter to start stent deployment; however the stent would not deploy.The device was removed from the body.It was then noted that the metal hypotube was bent then it broke in half.The physician opened a new vici stent on the same size and was able to complete the procedure.No patient complications were reported and the patient's status is fine.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 8776146
• Report Number: 2134265-2019-07983
• Device Sequence Number: 19332792
• Product Code: QAN
• UDI-Device Identifier: 00852725008171
• UDI-Public: 00852725008171
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P180013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0018100018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/10/2019
• Patient Sequence Number: 1