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

Catalog Number	142122-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Restenosis (4576); Swelling/ Edema (4577)
Date of Event	11/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is related to mdr number 3011632150-2024-00049.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 effects of claudication/pain, ischemia and restenosis leading to intervention are listed in the biomimics 3d instructions for use and are known patient effects 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
This is related to mdr number 3011632150-2024-00049.This patient was enrolled in the mimics 3d usa post-market observational registry study.On (b)(6) 2022, the patient was implanted with two biomimics 3d (bm3d) stents.A 6.0 x 150 mm stent was used treat a denovo lesion in the superficial femoral artery (sfa) distal third and a 6.0 x 60 mm stent (the subject of this report) was used to treat a denovo lesion in the proximal popliteal.Both stents were placed in the right leg.A contralateral approach was used and the lesions were pre-dilated with percutaneous transluminal angioplasty (pta).The treated segments were post-dilated with pta.On the (b)(6) 2022, the site identified a restenosis of treated segment (target lesion).It was reported as not related to the device and not related to the procedure but due to a worsening pre-existing condition.It was reported as not serious.It was reported as target lesion related.The patient had recurrent bilateral claudication, a repeat angiogram done on (b)(6) 2022 showed moderate-to-severe in-stent restenosis in the range of 70 - 80% in sfa.It was managed medically.An update on 16-aug-24 reported that during a clinic visit with the physician, the duplex ultrasound (dus) reported the following: "sfa patent w/moderate to severe if not severe mid and distal disease.Velocities in the popliteal artery are around 60".It was reported that the patient's symptoms had not changed much except for some leg swelling.The plan of care was to increase crestor, start lasix, and see the patient in one month for possible revascularisation at that time.The outcome was reported as continuing.The devices remain implanted.Veryan reviewed this event on the 04-sept-24 and it was considered possibly related to the device.
Event or Problem Description
This is related to mdr number 3011632150-2024-00049_01.This patient was enrolled in the mimics 3d usa post-market observational registry study.On (b)(6) 2022, the patient was implanted with two biomimics 3d (bm3d) stents.A 6.0 x 150 mm stent (the subject of this report) was used to treat a denovo lesion in the superficial femoral artery (sfa) distal third and a 6.0 x 60 mm stent was used to treat a denovo lesion in the proximal popliteal.Both stents were placed in the right leg.A contralateral approach was used and the lesions were pre-dilated with percutaneous transluminal angioplasty (pta).The treated segments were post-dilated with pta.On the (b)(6) 2022, the site identified a restenosis of treated segment (target lesion).It was reported as not related to the device and not related to the procedure but due to a worsening pre-existing condition.It was reported as not serious.It was reported as target lesion related.The patient had recurrent bilateral claudication, a repeat angiogram done on (b)(6) 2022 showed moderate-to-severe in-stent restenosis in the range of 70 - 80% in sfa.It was managed medically.An update on (b)(6) 2024 reported that during a clinic visit with the physician, the duplex ultrasound (dus) reported the following: "sfa patent w/moderate to severe if not severe mid and distal disease.Velocities in the popliteal artery are around 60".It was reported that the patient's symptoms had not changed much except for some leg swelling.The plan of care was to increase crestor, start lasix, and see the patient in one month for possible revascularisation at that time.The outcome was reported as continuing.The devices remain implanted.Veryan reviewed this event on the (b)(6) 2024 and it was considered possibly related to the device.Additional information was received on (b)(6) 2025, the patient was evaluated on (b)(6) 2024, recommended left lower revascularization especially occluded left sfa, however, patient experiencing aflutter which needed managing before any procedure.This event is ongoing, next follow-up is scheduled.For (b)(6) 2025 (outside of study 36-month window).Further information was received on 08-apr-2025: status of right sfa is unchanged.Last dus on (b)(6) 2024.No plans for revascularization of right leg at this time.The event is ongoing as of the patient study exit on (b)(6) 2025, the event remains reportable, a supplemental was required.
Additional Manufacturer Narrative
This is related to mdr number 3011632150-2024-00049_01.Additional information received, event remains reportable.The site reported that this event was ongoing as of the patient's study exit on (b)(6) 2025.This information requires an mdr supplemental report.Section b.5.Was updated with additional information received, section g3 was updated, sections g.6.And h.2.Were updated to reflect the report type (follow-up 01) and reason, and section h.11.Was updated to reflect 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: alan mcdonagh ; block 5; parkmore east business park; galway, H91 V-0TX ; EI H91 V0TX
• MDR Report Key: 20343850
• Report Number: 3011632150-2024-00050
• Device Sequence Number: 18128957
• Product Code: NIP
• UDI-Device Identifier: 05391526850398
• UDI-Public: (01)05391526850398(17)230605(11)211104(10)0000118074
• 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
• 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
• Report Date (Section B): 05/02/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/05/2023
• Device Catalogue Number: 142122-02
• Device Lot Number: 0000118074
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2021
• 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: ASPIRIN.; CILOSTAZOL (PLETAL).; CLOPIDOGREL (PLAVIX).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American