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

Catalog Number	144700-05
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Insufficient Information (4580)
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
The u.S.Food and drug administration (fda) received a medical device report (b)(4) via the medsun program concerning a biomimics 3d vascular stent system, it was reported as attempted to deliver stent but unsuccessful.Broke off on retrieval".The exact date was not reported it was documented as on (b)(6) 2025.The patient impact was not reported.
Event or Problem Description
The u.S.Food and drug administration (fda) received a medical device report (2201630000-2025-8003) via the medsun program concerning a biomimics 3d vascular stent system, it was reported as 'attempted to deliver stent but unsuccessful.Broke off on retrieval".The exact date was not reported it was documented as (b)(6) 2025.The patient impact was not reported.Despite multiple attempts by veryan to obtain more information in relation to this event, no additional details were provided.
Additional Manufacturer Narrative
The investigation was completed.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.Further information regarding the complaint procedure was not provided by the site despite the efforts made by veryan sales representatives to obtain information.There was no further information to provide in relation to this event.No additional details were received in relation to this complaint.The complaint was assigned a category "insufficient information" and the root cause could not be determined and remains unknown.It could not be established if the complaint was related to a deficiency of the device.Section b.5.Was updated with additional information following completion of the investigation.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 LTD; 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: 21419033
• Report Number: 3011632150-2025-00005
• Device Sequence Number: 7586352
• Product Code: NIP
• UDI-Device Identifier: 05391526850503
• UDI-Public: (01)05391526850503(17)260221(11)240723(10)0000360856
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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: 02/21/2026
• Device Catalogue Number: 144700-05
• Device Lot Number: 0000360856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Race: White