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

Catalog Number	144700-19
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is in progress.If any additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
On march 27, 2025, a veryan sales specialist received information that reported a fracture of a 7 x 150 mm biomimics 3d (bm3d) stent which was originally placed in (b)(6) 2024.
Additional Manufacturer Narrative
Following cmp completion the event was categorised as a distorted stent pattern with a potential that a type 1 stent fracture may also be present.Distorted stent pattern is assigned a severity of 3 and stent fractures are assigned a severity 4 in the ufmeca-1 version 19.0 and dfmeca-1 version 14.0.This means that they may lead to permanent impairment or life-threatening injury, this 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 the information received in this case, it remains unknown whether a stent fractured has occurred.However, the single image provided by the site for investigation does display that the stent is distorted following its deployment.Therefore, given the information that is available, the investigation concludes that is a "distorted stent pattern" case.It should also be noted that based on the image received, there is potential that a stent fracture could be present.Angiographic images and/or additional information regarding the procedure would be required in order to make an adequate determination regarding the reported stent fracture.Insufficient information was made available in this case in order to determine a root cause.No details regarding the deployment procedure, the ancillary devices, procedural events and/or the patient anatomy were provided.Therefore, the sequence of events and root cause of this complaint remain unknown.If additional information does become available, an addendum to this investigation will be opened.Section g.6 and h.2 were updated to reflect the type of report (follow up 01) and the reason and section h.6 and h.11 were updated to reflect the conclusions of the investigation and reflected the sections changed in this report.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Common Device Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL LIMITED; block 5; parkmore east business park; galway, H91 V 0TX; EI H91 V0TX
• Manufacturer Contact: caroline grealish ; block 5; parkmore east business park; galway, H91 V-0TX ; EI H91 V0TX
• MDR Report Key: 21908946
• Report Number: 3011632150-2025-00009
• Device Sequence Number: 8728553
• Product Code: NIP
• UDI-Device Identifier: 05391526850527
• UDI-Public: (01)05391526850527(17)260405(11)240904(0000375904)
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P180003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/15/2025

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: 04/05/2026
• Device Catalogue Number: 144700-19
• Device Lot Number: 0000375904
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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