MAUDE Adverse Event Report: VERYAN MEDICAL 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 Code	Restenosis (4576)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This report relates to mdr 3011632150-2024-00056.This patient was enrolled in the mimics 3d usa post-market observational registry study.On (b)(6) 2021, the patient was implanted with two biomimics 3d (bm3d) stents.A 7.0 x 100 mm stent and a 6.0 x 60 mm stent (the subject of this report) were used to treat a denovo lesion in the superficial femoral artery (sfa) middle third to sfa distal third in the right leg.A retrograde approach was used and the lesion was prepared with atherectomy and post-dilated with percutaneous transluminal angioplasty (pta) balloon.On (b)(6) 2023, 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 required percutaneous intervention.It was reported as target lesion related.The intervention was performed on (b)(6) 2023 on the sfa proximal third to distal popliteal segment.A non-bm3d bare metal stent was placed, pta/standard balloon angioplasty and laser atherectomy were used to treat the restenosis.It was a target lesion/vessel revascularisation (tlr/tvr).The site reported "pre-treatment - right sfa: 81.4% post-treatment - right mid sfa: 77%; right distal sfa: 91%".The outcome was reported as resolved with sequelae.The devices remain implanted.Veryan reviewed this event on 04-nov-2024 and it was considered possibly related to the device.
Additional Manufacturer Narrative
This report relates to mdr 3011632150-2024-00056.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 are 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.

• 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: 20833013
• Report Number: 3011632150-2024-00057
• Device Sequence Number: 11728211
• 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: WI
• 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): 12/03/2024

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
• 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: 11/04/2024
• Initial Report FDA Received Date: 12/03/2024
• 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; CLOPIDOGREL (PLAVIX)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 139 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White