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

Model Number	142122-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
There is no evidence to suggest that the device caused or contributed to this event.The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2021 to treat a denovo occlusion in the sfa proximal third to sfa middle third of the left leg.An event of restenosis of treated segment (target lesion) was originally reported to veryan on 04 feb 2022 as "not related" to the device or procedure.It was reported with the following comment "subject had complaints of recurrent severe claudication symptoms of bilateral lower extremity with mild rest pain and severe calf claudication.Angiogram showed 80% in-stent restenosis." the event was reviewed internally at a veryan safety review meeting on 07 feb 2022 and confirmed by veryan's chief medical officer that based on the in-stent restenosis, it is possibly device-related.The outcome of the event is reported as resolved/recovered.The device remains implanted.
Additional Manufacturer Narrative
There was no reported device malfunction and the device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to 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 additional surgical 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
There is no evidence to suggest that the device caused or contributed to this event.The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2021 to treat a denovo occlusion in the sfa proximal third to sfa middle third of the left leg.An event of restenosis of treated segment (target lesion) was originally reported to veryan on 04 feb 2022 as "not related" to the device or procedure.It was reported with the following comment "subject had complaints of recurrent severe claudication symptoms of bilateral lower extremity with mild rest pain and severe calf claudication.Angiogram showed 80% in-stent restenosis." the event was reviewed internally at a veryan safety review meeting on 07 feb 2022 and confirmed by veryan's chief medical officer that based on the in-stent restenosis, it is possibly device-related.The outcome of the event is reported as resolved/recovered.The device remains implanted.
Additional Manufacturer Narrative
There was no reported device malfunction and the device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to 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 additional surgical 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.

• 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 city, H91 V E0H; EI H91 VE0H
• Manufacturer Contact: alan mcdonagh ; unit 11 galway technology park; parkmore road; galway, H91 V-EOH ; EI H91 VEOH
• MDR Report Key: 13598166
• Report Number: 3011632150-2022-00009
• Device Sequence Number: 13945418
• Product Code: NIP
• UDI-Device Identifier: 05391526850497
• UDI-Public: (01)05391526850497(17)220320(11)200819(10)0000049876
• 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): 02/25/2022

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: 03/20/2022
• Device Model Number: 142122-15
• Device Catalogue Number: 142122-15
• Device Lot Number: 0000049876
• 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: 02/07/2022
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2020
• 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; CLOPIDOGREL (PLAVIX)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White