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

Model Number	142122-13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Restenosis (4576)
Date of Event	12/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to mdr report 3011632150-2023-00003.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-conformance's 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 restenosis leading to intervention and claudication/pain 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 report is related to mdr report 3011632150-2023-00003.The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6) 2021, the patient was implanted with two biomimics 3d stents.One a 5.0 x 125mm stent (the subject of this report) and a 6.0 x 60mm to treat a denovo lesion of the superficial femoral artery (sfa) middle third to sfa distal third segment in the left leg.A contralateral approach was used and the lesion was prepared using atherectomy and pre-dilated with percutaneous transluminal angioplasty (pta).The lesion was post-dilated with pta.The site reported that on (b)(6) 2022, a restenosis of treated segment (target lesion) was identified.It was reported as not related to the device or the procedure but due to a worsening of the pre-existing condition and it was reported as target lesion related.The patient was complaining of right leg claudication (non-target limb) on (b)(6) 2022 during an office visit.Bilateral ankle brachial index measurements (abi) declined on (b)(6) 2022.The patient was then scheduled for a right leg angiogram on (b)(6)2022 and left leg angiogram on (b)(6) 2022.A left leg extremity (lle) angiogram was conducted and showed 100% occlusions of biomimics stents.The intervention involved laser atherectomy and pta / standard balloon angioplasty on (b)(6) 2022 on the sfa ostial to sfa distal third segment with good results.The physician also reported that the patient complained of left leg claudication but just not as significant as the right.The site reported this as clinically driven target lesion revascularisation.This was reported as a target lesion revascularisation (tlr)/target vessel revascularisation (tvr).This event was reviewed by veryan on 19-dec-22 and considered possibly related to the device.The patient outcome was reported as resolved/recovered and the devices remain implanted.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Common Device Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL LTD; unit 11 galway technology park; parkmore road; galway, H91 V E0H; EI H91 VE0H
• Manufacturer Contact: alan mcdonagh ; unit 11 galway technology park; parkmore road; galway, H91VE-0H ; EI H91VE0H
• MDR Report Key: 16172808
• Report Number: 3011632150-2023-00002
• Device Sequence Number: 2331681
• Product Code: NIP
• UDI-Device Identifier: 05391526850473
• UDI-Public: (01)05391526850473(17)220617(11)201116(10)0000058439
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 01/16/2023

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: 06/17/2022
• Device Model Number: 142122-13
• Device Catalogue Number: 142122-13
• Device Lot Number: 0000058439
• 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: 12/19/2022
• Initial Report FDA Received Date: 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• 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)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White