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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENITI, INC. VICI
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VENITI, INC. VICI Back to Search Results
Model Number 26930
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/12/2021
Event Type  malfunction  
Event Description
It was reported that there was foreign material in the device.A 16mm x 90mm x 100cm vici stent system was selected for use in an iliac vein stenting procedure.During preparation, the stent was flushed, and blue lint-like particles were continuously flushed out of it.The procedure was completed with a new stent.No patient complications were reported, and the patient had a good outcome.
 
Event Description
It was reported that there was foreign material in the device.A 16mm x 90mm x 100cm vici stent system was selected for use in an iliac vein stenting procedure.During preparation, the stent was flushed, and blue lint-like particles were continuously flushed out of it.The procedure was completed with a new stent.No patient complications were reported, and the patient had a good outcome.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was received with the stent fully constrained in the correct position the delivery system.A visual and tactile inspection identified no kinks or damage to the delivery system of the device.The investigator attached a syringe to both the flushing port and guidewire port of the device and successfully flushed both the device and the guidewire lumen without issue.No foreign material (fm) was identified exiting from any part of the device when flushed.A visual and tactile examination found the stainless-steel shaft of the device to be severely kinked at the center.This type of damage is consistent with excessive force being applied to the device.A visual and tactile examination identified no issues with the tip of the device.
 
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Brand Name
VICI
Manufacturer (Section D)
VENITI, INC.
4025 clipper court
fremont CA 94538
MDR Report Key11409002
MDR Text Key234684259
Report Number2134265-2021-02692
Device Sequence Number1
Product Code QAN
UDI-Device Identifier00852725008164
UDI-Public00852725008164
Combination Product (y/n)N
PMA/PMN Number
P180013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2023
Device Model Number26930
Device Catalogue Number26930
Device Lot Number0020080043
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2021
Date Manufacturer Received04/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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