MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number	26930
Medical Device Problem Codes	Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent partially deployed.Two vici stents were selected for a subclavian vein venogram procedure to treat stenosis secondary to pacemaker leads.Access was at the biracial vein using a 9f short introducer sheath.Pre-dilatation was performed.During the procedure, the first 12x90 vici stent was deployed normally.The second stent, a 12x60x100 vici stent, was overlapped with the first.The distal end of the stent did not deploy, although the proximal end did.The nose cone became caught on the edge of the stent.With some manipulation, it was able to be removed.The stent was post dilated with a balloon catheter.The final result was good and the stent appeared to be in good condition.There were no patient complications and the patient was stable post procedure.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 9432103
• Report Number: 2134265-2019-15109
• Device Sequence Number: 1711086
• Product Code: QAN
• UDI-Device Identifier: 00852725008096
• UDI-Public: 00852725008096
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 12/06/2019

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: 06/30/2022
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0019060010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1