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

Model Number	144700-05
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Restenosis (4576)
Date of Event	12/10/2021
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 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 effects of restenosis leading to intervention is 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
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 middle third to distal third of the left leg.An event of restenosis of treated segment (target lesion) was originally reported to veryan as not related to the device but on review of the event as this led to a revascularisation on the target lesion it was considered possibly related to the device.The intervention included non biomimics 3d stent placement, percutaneous transluminal angioplasty / standard balloon angioplasty, laser/atherectomy.The outcome of the event is reported as resolved/recovered.The device remains implanted.
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 middle third to distal third of the left leg.A retrograde approach was used and the lesion was prepared using atherectomy and pre-dilation with a standard balloon an event of restenosis of treated segment (target lesion) was originally reported to veryan as "not related" to the device.This relationship was updated to "possibly related" on the (b)(6) 22 by the site.On review of the event as this led to a revascularisation on the target lesion it was considered possibly related to the device originally.The intervention included non biomimics 3d stent placement, percutaneous transluminal angioplasty / standard balloon angioplasty, laser/atherectomy.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 effects of restenosis leading to intervention is listed in the biomimics 3d instructions for use and are known patient effects of peripheral stenting procedures.Section b.5.Was updated based on the additional information received.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.
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 effects of leg pain/claudication and restenosis leading to intervention is 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.Sections b.5., b.7., d.10., e.1., h.6., and h.10.Have been updated.
Event or Problem Description
The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2021.A biomimics 3d (bm3d) 5.0 x 150mm stent was used to treat a denovo lesion in the superficial femoral artery (sfa) middle third to distal third in the left leg.A retrograde approach was used and the lesion was prepared using atherectomy and pre-dilation with percutaneous transluminal angioplasty (pta) / standard balloon.An event of restenosis of treated segment (target lesion) was identified by the site on (b)(6) 2021.It was reported by the site as possibly related to the device and not related to the procedure.The patient was experiencing leg pain and was seen in the clinic on (b)(6) 2021.A computed tomography angiography (cta) of the lower extremities was performed and showed bilateral sub-total occlusion of stents.The patient underwent intervention of left leg (target) on (b)(6) 2022.Access was gained at the left anterior artery, which was found to have 90% stenosis proximally.Laser atherectomy and pta was performed in proximal anterior tibial artery (ata) in order to proceed to sfa.There was in-stent restenosis (isr) in the distal sfa extending in to denovo lesion just distal to the stent.The worst stenosis here was 70%.A separate denovo lesion in the proximal sfa just above target stent had 90% stenosis.Laser atherectomy was performed throughout sfa, followed by pta/standard balloon angioplasty.A 6.0 x 120mm stent was placed in the proximal sfa and overlapping the target bm3d stent.A 5mm x 120 mm stent was placed in the distal sfa covering the isr and the distal de novo lesion.The stents were post-dilated with pta.The intervention was reported as a target lesion/vessel revascularisation of the sfa proximal third to distal third.The outcome of the event is reported as resolved/recovered.The device remains 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 city, H91 V E0H; EI H91 VE0H
• Manufacturer Contact: alan mcdonagh ; unit 11 galway technology park; parkmore road; galway city, H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 14192769
• Report Number: 3011632150-2022-00018
• Device Sequence Number: 19928298
• Product Code: NIP
• UDI-Device Identifier: 05391526850503
• UDI-Public: (01)05391526850503(17)220617(11)201116(10)0000058640
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2023

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: 144700-05
• Device Catalogue Number: 144700-05
• Device Lot Number: 0000058640
• 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: 03/28/2022
• Supplement Date Received by Manufacturer: 08/30/2022; 04/06/2023
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 09/27/2022; 05/04/2023
• 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; ASPIRIN; CLOPIDOGREL (PLAVIX); CLOPIDOGREL (PLAVIX); HEPARIN IV; HEPARIN IV
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White