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

Catalog Number	142122-02
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Insufficient Information (4580)
Date of Event	01/06/2026
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 on (b)(6) 2026, a patient presented with a chronic total occlusion (cto) after a biomimics stent 6x60 was implanted on (b)(6) 2025.An angio was taken to verify that the stent had fractured in the right femoropopliteal segment.It was noted that the entire superficial femoral artery (sfa)/popliteal artery (pop) was occluded with various stents that were implanted since early 2023.It was noted that the segment occluded twice prior to the implant of the 6x60mm biomimics stent.Thrombectomy was performed followed by placement of a competitor stent over the fractured biomimics.
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 the feedback in this case, as well as the review of the complaint images, it is understood that a type 1 stent fracture; single strut fracture, has occurred in this case.Based on the angiographic images provided by the site, it is understood that no stent fracture was present upon deployment of the stent during the index procedure on (b)(6) 2026 then, the biomimics 3d stent was seen to posses a type 1 stent fracture - single strut fracture, at the follow-up procedure on (b)(6)2026.Given that no endovascular procedure took place between the index procedure and the re-intervention, this implies that the fracture took place between (b)(6)2025 and (b)(6)2026, and the remaining possible explanation for the fracture is due to material fatigue as a result of physiological loading.It is important to note that stent fracture from physiological loading is an anticipated outcome for femoropopliteal stents.Therefore, the type 1 stent fracture seen in this case does not indicate that the biomimics 3d stent has a design flaw.The veryan medical opinion is that the type 1 stent fracture in this complaint is most likely explained by movement of the sfa where it passes the adductor canal (hunter's canal) and changes name to the popliteal artery.This region of the patient anatomy is likely the region in which the movement during knee flexion is substantial.The biomimics 3d stent is tested under simulated physiological loading conditions, combined compression and bending, and separate pulsatile up to 10 years of life.Anatomically, the adductor canal is a relatively straight muscular channel that transitions distally into a less constrained pocket region as the tendons narrow toward the bone.This region of the sfa is known to experience significant biomechanical loads during limb movement.In cases where an extensive segment of the sfa is stented, such as this complaint case, the natural compliance of the vessel may be reduced.The native artery can accommodate a portion of deformation (compression) during limb flexion, when this compliance is limited, a greater proportion of mechanical strain can be transferred to the less constrained stented segment.This could contribute to higher than usual localised stresses in vulnerable regions.Based on the information received in this case, it is understood that re-occlusion occurred within the target site.It is important to note that this patient has a very high risk of re-occlusion, due to the following risk factors: metastatic renal cancer, adiposity, a long stented sfa, and previous occlusions.Therefore, this investigation concludes that it is unlikely that the stent fracture seen in this is the cause for the re-occlusion.It is most likely that the re-occlusion is the result of a contribution from the patient condition and the disease within the stented area.
Event or Problem Description
It was further reported that on (b)(6) 2025, a 6x60 mm biomimics 3d stent that was successfully placed in the right distal sfa/popliteal artery of a patient.Feedback was given that no resistance or issues were encountered during the deployment of the device.It was also noted that the biomimics 3d stent pattern was in good condition and did not display any distortion.Good results were achieved in the deployment procedure.A patient history was provided by the complaint site.It is important to note that the entire length of the right sfa/popliteal artery has been treated with various stents since early 2023 as means to treat occlusion.This target site experienced re-occlusion twice prior to the implant of the biomimics 3d 6x60 mm stent.Additionally, the patient has a history of chronic heart failure, metastatic renal cancer and adiposity.On (b)(6)2026, the patient presented with right lower limb pain.Upon inspection, the physician determined that the right sfa had re-occluded, and that a potential stent fracture was present.The physician treated the patient by performing a thrombolysis and by placing a competitor stent over the potentially fractured biomimics 3d stent.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Common Device Name: BIOMIMICS 3D VASCULAR STENT SYSTEMBIOMIMICS 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: 24207085
• Report Number: 3011632150-2026-00025
• Device Sequence Number: 20204682
• Product Code: NIP
• UDI-Device Identifier: 05391526850398
• UDI-Public: (01)05391526850398(17)260206(11)240708(10)0000358014
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 03/31/2026

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 Expiration Date: 02/06/2026
• Device Catalogue Number: 142122-02
• Device Lot Number: 0000358014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2024
• 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