MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number	26930
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties occurred.The patient was being treated for may thurner syndrome.A 10f sheath and a 14 x 90 x 100 vici self expanding stent were selected for use to treat the lesion.Stent deployment difficulty was encountered and the stent did not deploy inside the patient.During the removal of the stent delivery system, removal difficulties were encountered.The stent delivery system was able to be fully removed from the patient.There were no patient complications.
Event or Problem Description
It was reported that removal difficulties occurred.The patient was being treated for may thurner syndrome.A 10f sheath and a 14x90x100 vici self expanding stent were selected for use to treat the lesion.Stent deployment difficulty was encountered and the stent did not deploy inside the patient.During the removal of the stent delivery system, removal difficulties were encountered.The stent delivery system was able to be fully removed from the patient.There were no patient complications.It was further reported that the target lesion was located in the common iliac vein.When the device was removed from the patient, additional stent deployment occurred on the back table.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned in a condition that did not have significant damage or kinks.The stent was observed to be partially deployed form the delivery system (approximately 20mm) when it was returned.Additionally, the nosecone had been pulled back into the outershaft of the delivery system.Where the nosecone had been pulled back into the delivery system, the outershaft was visibly deformed/flared.During the decontamination process the device became kinked.The kink of the outershaft was severe and resulted in a kink in the inner shaft.The portion of the stent that was partially deployed was inspected and there was evidence of slight deformation of some of the stent bridges that were nearest to the area in which the stent was wedged between the outershaft and retracted/fully seated nosecone.The nosecone was advanced to its expected position which confirmed the deformation to the stent in that location was permanent.No anomalies or deformation was noted on the stent portion that remained crimped into the outershaft.The innershaft was reinserted and deployment force tested was conducted.As the stent was already partially deployed, the delivery device could only be tracked around the outside of the anatomical model.The stent system was advanced over an.035, 150cm guidewire.Deployment of the remaining portion of the sheathed stent required very little amount of force.Visual inspection of the deployed stent identified the two locations of slight bridge deformation that were noted prior to deployment.The slight deformation noted did not result in the struts protruding into the lumen of the stent or out of plane from the od of the stent.Additionally, the deformation identified was not to the extent that it would have failed any of the defined visual inspection criteria.The stent was reloaded into the same delivery system stent and in the same orientation as it was originally loaded.There were no difficulties noted when loading the stent into the delivery system.Once reloaded, the stent was deployed with a 10fr access sheath into the illiac venous system model.The 10 fr sheath was utilized to replicate the device use in the reported case.Despite the kink in the outershaft and innershaft, the stent deployment within the typical deployment values.Based on the returned device condition, the difficulty to deploy was confirmed.However, the device evaluation identified no potential defects that would have caused or contributed to the reported event.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 8925002
• Report Number: 2134265-2019-10207
• Device Sequence Number: 11314228
• Product Code: QAN
• UDI-Device Identifier: 00852725008133
• UDI-Public: 00852725008133
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/19/2019

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: 03/31/2022
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0019020019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10F TERUMO PINNACLE SHEATH, 10 CM.