MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number 26930

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 02/08/2021

Event Type  Injury  

Manufacturer Narrative

Age at time of event: patient was in his (b)(6) years old.

Event Description

It was reported that partial stent deployment and venous tissue detachment occurred.The patient presented with may-thurner compression.There was compression in the common iliac and there was chronic deep vein thrombosis in the iliac system.It was also noted that there were a lot of para-venous fibrosis through both external and common iliac.The target lesion was pre-dilated with a 12mm balloon catheter.The lesion quickly closed due to the compression within the iliac.A 14x60mm, 100cm vici self expanding stent was advanced and deployed.The proximal end of the stent remained crimped to the delivery system and the stent did not fully deploy from the delivery system.The partially deployed stent was removed from the lesion by turning it on itself and pulling it back through the vessel and through the sheath.Once the stent was removed from the patient the stent was inspected.There appeared to be fibrous tissue around the tip of the catheter.The procedure was completed by using another stent of a different size.Imaging was performed and there was no damage noted to the patient.

Manufacturer Narrative

A2: age at time of event: patient was in his 50s years old.Device eval by mfr: the device was received with the stent fully deployed from the delivery system.At approximately 10mm distal of its distal end, the stent was tightly constrained to the tip of the device by an unknown material.For investigation purposes the investigator removed the material from the stent to carry out further analysis and assess the composition of the material.An examination of the unconstrained stent found no issues or damage.A visual and tactile inspection identified no kinks or damage to the delivery system or shaft of the device.Another sample of unknown material was found to be tightly wrapped around the inner shaft of the device.It is possible that this material is of the same origin as the sample found on the stent.A visual and tactile examination identified no issues with the tip of the device.Fourier-transform infrared spectroscopy analysis of the foreign material confirmed that the tissue identified on the stent was biological which would suggest that the origin was the anatomy of the patient.

Event Description

It was reported that partial stent deployment and venous tissue detachment occurred.The patient presented with may-thurner compression.There was compression in the common iliac and there was chronic deep vein thrombosis in the iliac system.It was also noted that there were a lot of para-venous fibrosis through both external and common iliac.The target lesion was pre-dilated with a 12mm balloon catheter.The lesion quickly closed due to the compression within the iliac.A 14x60mm, 100cm vici self expanding stent was advanced and deployed.The proximal end of the stent remained crimped to the delivery system and the stent did not fully deploy from the delivery system.The partially deployed stent was removed from the lesion by turning it on itself and pulling it back through the vessel and through the sheath.Once the stent was removed from the patient the stent was inspected.There appeared to be fibrous tissue around the tip of the catheter.The procedure was completed by using another stent of a different size.Imaging was performed and there was no damage noted to the patient.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 11401718
• MDR Text Key: 234393156
• Report Number: 2134265-2021-02299
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00852725008126
• UDI-Public: 00852725008126
• Combination Product (y/n): N
• PMA/PMN Number: P180013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0020010014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Date Manufacturer Received: 04/01/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other