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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
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
It was reported that a biomimics stent was partially deployed and the handle broke.Upon trying to remove the stent delivery system, the distal end of the stent deployed in the artery and fractured into pieces.The entire delivery system was removed and the stent fragments were extracted with a snare.A second stent was deployed without incident in the left above knee popliteal segment.

• 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: 24950812
• Report Number: 3011632150-2026-00026
• Device Sequence Number: 17462935
• Product Code: NIP
• UDI-Device Identifier: 05391526850503
• UDI-Public: (01)05391526850503(17)261010(11)250311(10)0000427407
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P180003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 06/25/2026

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 Catalogue Number: 144700-05
• Device Lot Number: 0000427407
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2025
• 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