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

Catalog Number	144700-19
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	03/02/2022
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 restenosis leading to intervention is listed in the biomimics 3d instructions for use and 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) 2021.The subject was implanted with one biomimics 3d (bm3d) stent (a 7.0 x 150mm stent) to treat a restenotic lesion of the sfa middle third to sfa distal third artery in the right leg.A contralateral approach was used and the lesion was prepared using pre-dilatation with percutaneous transluminal angioplasty (pta) and laser atherectomy.The treated segment was post-dilated with pta.On (b)(6) 2022, an event of restenosis of treated segment (target lesion) was identified by the site.It was reported as "not related" to the device and "not related" to the procedure but worsening pre-existing condition.It was target lesion-related.The right sfa stent was treated with plain old balloon angioplasty (poba) for in-stent restenosis (isr).The right ostial sfa stenosis was treated with laser atherectomy and poba.The intervention was performed on (b)(6) 2022 and the segment treated was the sfa ostial to proximal popliteal.The patient outcome was reported as "resolved/recovered".It was reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).The device remains implanted.This was reviewed by veryan on 05-mar-24 and considered possibly related to the bm3d device.

• 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: 19032790
• Report Number: 3011632150-2024-00014
• Device Sequence Number: 8167299
• Product Code: NIP
• UDI-Device Identifier: 05391526850527
• UDI-Public: (01)05391526850527(17)220611(11)201110(10)0000056112
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P180003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2024

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 Catalogue Number: 144700-19
• Device Lot Number: 0000056112
• 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: 03/05/2024
• Initial Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2020
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Hispanic