MAUDE Adverse Event Report: VERYAN MEDICAL LTD. BIOMIMICS 3D VASCULAR STENT SYSTEM

Catalog Number	144700-12
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Activation Failure (3270)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is in progress.If any additional information becomes available a supplemental/follow-up report will be submitted.
Event or Problem Description
On 07-16-25, a veryan clinical sales specialist received information that the physician described having difficultly deploying a 6 x 150 mm biomimics 3d stent.The first stent deployed as expected, and the second stent deployed about 20-30 cm and it was reported that the catheter broke.The physician was able to deploy the stent and the patient required no further intervention.
Additional Manufacturer Narrative
Complaint complete and event remains reportable.A detailed review of all the lot history records pertaining to the relevant stent and delivery system lots showed no issues that were deemed related to the complaint investigation.Based on feedback in this case, as well as the investigation of the returned device, it is understood that increased resistance was experienced during the deployment in this case, which resulted in the failure of the bifurcation hub to outer braid bond.When bond failure is seen, it suggests that a significantly high deployment force occurred.Additional physical evidence in the returned device; the braid lengths being elongated outside of its specifications, supports that the deployment force was high in this case.The root cause of the high deployment force in this case is the anatomical conditions of the patient, which included occlusion throughout the entire length of the sfa, as well as moderate calcification.These factors would have contributed to increased friction between the delivery system components, and between the delivery system and guide/introducer sheath during the stent deployment.Veryan is aware that difficult anatomical conditions can contribute to increased resistance during deployment, as was the case in this complaint.Veryan is aware that difficult anatomical conditions can contribute to increased resistance during deployment, as was the case in this complaint.Ufmeca-1 version 19.0 line items #99-113 documents the potential hazardous situations associated with resistance being present during deployment.Based on the feedback received in this case, it is also understood that the physician released the full length of the stent by use of hemostats following the partial deployment that had occurred.This is contrary to the instructions for deploying the biomimics 3d device as per the 'stent deployment procedure' section of ifu-3 version 4.0.However, it is important to note that the investigation is aware that following the partial deployment the physician was no longer in a position to deploy the device as per procedure.The investigation concludes that this is a 'partial deployment' case, which was caused by increased resistance during deployment, and the complaint is not related to a deficiency with the device.
Event or Problem Description
It was further reported that there were no adverse effects on the patient as a result of this case.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Common Device Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL LTD.; block 5; parkmore east business park; galway, H91V0 TX; EI H91V0TX
• Manufacturer Contact: hannah duffy ; block 5; parkmore east business park; galway, H91V0-TX ; EI H91V0TX
• MDR Report Key: 22813539
• Report Number: 3011632150-2025-00019
• Device Sequence Number: 8703520
• Product Code: NIP
• UDI-Device Identifier: 05391526850510
• UDI-Public: (01)05391526850510(17)260501(11)240930(10)0000382193
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P180003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2025

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: 01/05/2026
• Device Catalogue Number: 144700-12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown