MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number	26930
Medical Device Problem Codes	Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Device-Device Incompatibility (2919); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent partially deployed and removal difficulties occurred.A 16x120mm,100cm vici self expanding stent was selected for use to treat the lesion.During deployment of the stent, it became caught on a previously placed vici stent on the right side near the confluence.This prevented the stent to fully deploy.Attempts were made to remove the partially deployed stent; however, the stent was getting caught on another placed stent.Eventually the physician was able to remove the stent and the procedure was completed with a new stent of a different size.No patient complications were reported.
Event or Problem Description
It was reported that the stent positioning difficulties were encountered.A 16x120mm,100cm vici self expanding stent was selected for use to treat the lesion.During deployment of the stent, it became caught on a previously placed vici stent on the right side near the confluence.This prevented the stent to fully deploy.Attempts were made to remove the partially deployed stent; however, the stent was getting caught on another placed stent.Eventually the physician was able to remove the stent and the procedure was completed with a new stent of a different size.No patient complications were reported.
Additional Manufacturer Narrative
Correction to h6 device codes.Initially reported as activation, positioning or separation problem 2906 the h6 code is corrected to positioning problem 3009.Device evaluated by manufacturer: the device was received with the stent partially deployed.The stent could not be fully deployed due to severe damage to the outer shaft of the device.A visual and tactile examination of the tip identified no damage or issues with the tip of the device.A visual and tactile examination of the shaft identified severe kinking and a complete break of the outer shaft of the device located approximately 100mm proximal of the distal end of the shaft.This type of damage is consistent with excessive force being applied to the device.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 9830031
• Report Number: 2134265-2020-03133
• Device Sequence Number: 11470676
• Product Code: QAN
• UDI-Device Identifier: 00852725008171
• UDI-Public: 00852725008171
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 04/17/2020

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: 10/31/2022
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0019100019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 04/17/2020
• Patient Sequence Number: 1
• Patient Age: 63 YR