MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number	26930
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The stent was returned partially deployed from the delivery system.The distal stent wires were noted to be damaged.This type of damage is consistent with the stent encountering resistance during deployment.A visual and tactile examination found the shaft of the device to be severely kinked at approximately 35mm distal of the main valve.This type of damage is consistent with excessive force being applied to the device.The investigator successfully deployed the stent with some resistance experienced due to a severe shaft kink.A visual and tactile examination identified no issues with the tip of the device.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 11dec2020.It was reported the stent failed to deploy.A 16mmx120mm, 100cm vici was selected for use.During the procedure, the stent failed to deploy.The device was removed from the patient.Another of the same device was used to complete the procedure.There were no patient complications.However, device analysis revealed that the stent was partially deployed and damaged.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 11003746
• Report Number: 2134265-2020-17641
• Device Sequence Number: 3477612
• Product Code: QAN
• UDI-Device Identifier: 00852725008171
• UDI-Public: 00852725008171
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2020

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: 01/31/2023
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0020010022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 12/14/2020
• Patient Sequence Number: 1
• Patient Age: 73 YR