MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number	26930
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tip fracture occurred.A 16 x 60 x 100 vici self-expanding stent was selected for use to treat a narrow and tortuous renal vein.The stent delivery system was loaded onto a guidewire while external to the patient.However, the tip of the stent shaft detached.A new device, same model, was advanced over the guidewire and used to complete the procedure.
Additional Manufacturer Narrative
Device eval.By manufacturer: upon receipt at our post market quality assurance laboratory, this vici self-expanding stent was inspected.The device was received with the distal stent wires flush, with the distal edge of the blue outer shaft.This is evidence of stent partial deployment on the delivery system.No other issues were noted with the stent.A visual and tactile inspection identified a complete break of the inner shaft located approximately 01mm proximal of the distal tip.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination identified no issues with the tip of the device.
Event or Problem Description
It was reported that a shaft fracture occurred.A 16x60x100 vici self-expanding stent was selected for use to treat a narrow and tortuous renal vein.The stent delivery system was loaded onto a guidewire while external to the patient.However, the tip of the stent shaft detached.A new device, same model, was advanced over the guidewire and used to complete the procedure.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 11622093
• Report Number: 2134265-2021-04346
• Device Sequence Number: 19604461
• Product Code: QAN
• UDI-Device Identifier: 00852725008157
• UDI-Public: 00852725008157
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P180013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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: 08/31/2023
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0020080023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 05/06/2021
• Patient Sequence Number: 1