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

Catalog Number	142122-07
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no reported device malfunction and the device was not returned for analysis.A review has been performed of the manufacturing certificate of conformance associated with this lot.There were no non-conformances or deviations which could be associated with this event.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effect of occlusion leading to intervention is a known patient effect of peripheral stenting procedures.There is no indication of a product quality issue with respect to the design, manufacture or labelling of the device.If further information regarding this event becomes available, a follow-up report will be submitted.
Event or Problem Description
The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6) 2022, the patient was implanted with one biomimics 3d (bm3d) stent, one 7.0 x 80 mm stent to treat a denovo lesion in the superficial femoral artery (sfa) proximal third in the left leg.A retrograde approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was post-dilated with pta.On 05-feb-24, an occlusion was identified.It was reported as not related to the device or the procedure.It was related to concomitant medication but required medication to treat.The outcome was reported as continuing.The occlusion was in the proximal to mid aspect of the left sfa.The patient's status was reported as being asymptomatic from an arterial standpoint, post bilateral lower extremity revascularisation (initial procedure on (b)(6) 2022).There was no claudication or rest pain, no ulcerations and no upcoming podiatric surgery.Imaging taken on 05-feb-24 showed multilevel flow-limiting arterial disease bilaterally with occluded sfa arteries bilaterally.There were mildly diminished ankle-brachial index (abi) measurements and adequate toe-brachial indexes (tbis) bilaterally.The imaging findings and pathophysiology of the peripheral arterial disease (pad) were discussed between the physician and the patient.It was reported that she remains asymptomatic.There was no indication for further intervention.The importance of robust risk factor modification including encouragement by the physician to walk as much as possible to facilitate collateralisation.A follow-up visit was planned in six months with abis/tbis for routine monitoring purposes.The physician reviewed the signs and symptoms that would indicate urgent evaluation with the patient.The patient had venous insufficiency with palpable knots and visible spider veins to bilateral lower extremities.Imaging at a previous clinic visit demonstrated a small amount of venous insufficiency bilaterally below the knee.There was shared decision-making to hold off on ablative therapy.The patient was encouraged to continue the use of compression stockings.The device remains implanted.
Additional Manufacturer Narrative
There was no reported device malfunction and the device was not returned for analysis.A review has been performed of the manufacturing certificate of conformance associated with this lot.There were no non-conformances or deviations which could be associated with this event.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effect of occlusion leading to intervention is a known patient effect of peripheral stenting procedures.There is no indication of a product quality issue with respect to the design, manufacture or labelling of the device.If further information regarding this event becomes available, a follow-up report will be submitted.Section a.2.And section b.3.Were updated with the patient's age and the date of onset of the event, section b.5.Was updated, section b.7.Was updated to add that it was unknown if the patient had a non-healing wound on the target limb at baseline, sections g.6.And h.2.Were updated to reflect the type of report (follow-up 01) and the reason and section h.11.Was updated to reflect the sections that have changed in this report.
Event or Problem Description
The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6) 2022, the patient was implanted with one biomimics 3d (bm3d) stent, one 7.0 x 80 mm stent to treat a denovo lesion in the superficial femoral artery (sfa) proximal third in the left leg.A retrograde approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was post-dilated with pta.On (b)(6) 2022, an occlusion was identified.It was reported as not related to the device or the procedure.It was related to concomitant medication but required medication to treat it.The outcome was reported as continuing.The occlusion was in the proximal to mid aspect of the left sfa.The patient's status was reported as being asymptomatic from an arterial standpoint, post bilateral lower extremity revascularisation (initial procedure on (b)(6) 2022).There was no claudication or rest pain, no ulcerations and no upcoming podiatric surgery.Imaging taken showed multilevel flow-limiting arterial disease bilaterally with occluded sfa arteries bilaterally.There were mildly diminished ankle-brachial index (abi) measurements and adequate toe-brachial indexes (tbis) bilaterally.The imaging findings and pathophysiology of the peripheral arterial disease (pad) were discussed between the physician and the patient.It was reported that she remains asymptomatic.There was no indication for further intervention.The importance of robust risk factor modification including encouragement by the physician to walk as much as possible to facilitate collateralisation.A follow-up visit was planned in six months with abis/tbis for routine monitoring purposes.The physician reviewed the signs and symptoms that would indicate urgent evaluation with the patient.The patient had venous insufficiency with palpable knots and visible spider veins to bilateral lower extremities.Imaging at a previous clinic visit demonstrated a small amount of venous insufficiency bilaterally below the knee.There was shared decision-making to hold off on ablative therapy.The patient was encouraged to continue the use of compression stockings.The device remains implanted.Additional information received by the site on (b)(6) 2024 updated the date of onset of the event from (b)(6) 2024 to (b)(6) 2022, and the patient's age at the time was also revised as a result of this change.
Event or Problem Description
It was further reported that the study was ongoing at the patient's exit from the study.
Event or Problem Description
It was further reported that following the clinical events committee (cec) adjudication on 13-nov-25, the event was determined to be related to the study device.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Common Device Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL; block 5; parkmore east business park; galway, H91 V 0TX; EI H91 V0TX
• Manufacturer Contact: alan mcdonagh ; block 5; parkmore east business park; galway, H91 V-0TX ; EI H91 V0TX
• MDR Report Key: 18912009
• Report Number: 3011632150-2024-00009
• Device Sequence Number: 6759796
• Product Code: NIP
• UDI-Device Identifier: 05391526850435
• UDI-Public: (01)05391526850435(17)231107(11)220408(10)0000144051
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P180003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 11/07/2023
• Device Catalogue Number: 142122-07
• Device Lot Number: 0000144051
• 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: 02/19/2024
• Supplement Date Received by Manufacturer: 04/04/2024; Not provided; 11/18/2025
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/29/2024; 10/15/2025; 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CLOPIDOGREL (PLAVIX); XARELTO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 206 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White