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

Catalog Number	142122-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is related to mdr number 3011632150-2023-00091.The patient was treated as part of the mimics 3d usa post-market observational study.On the (b)(6)2022, the patient was implanted with two biomimics 3d (bm3d) stents in the left leg, a 7.0 x 125 mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) middle third to proximal popliteal segment and a 7.0 x 60 mm stent (the subject of this report) which was used to treat a denovo lesion of the sfa proximal third segment.A contralateral approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon.The treated segment was post-dilated with pta.The site identified a restenosis of treated segment (target lesion) on (b)(6)2022.It was reported as possibly related to the device and not related to the procedure.It was also reported as target lesion related.The patient had a computed tomography angiography (cta) of the abdominal aorta and bilateral lower extremity runoff on (b)(6)2022 which showed that the left lower extremity (lle) sfa was occluded at the ostium including occlusion of the two bm3d stents.The patient returned for an office visit on (b)(6)2022 and left to consider whether to have a revascularization procedure on the target lesion.The patient returned on 1(b)(6)2023 for his 12-month study visit, his ultrasound showed occluded bm3d stents.He was taken in for an angiogram on (b)(6)2023 for an attempt at revascularization.However, both stents were occluded and the physician was unable to cross either occlusion in the true lumen.The patient returned on (b)(6)2023 and had a left common femoral to proximal popliteal bypass with polytetrafluoroethylene (ptfe) graft and left femoral endarterectomy.The procedure went well with no complications.The patient remained in the hospital until (b)(6)2023 when he was discharged home with physical therapist (pt) orders.The intervention was reported as a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.The devices remain implanted.
Additional Manufacturer Narrative
This report is related to mdr number 3011632150-2023-00091.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 effects 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.

• 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: 17406571
• Report Number: 3011632150-2023-00092
• Device Sequence Number: 12274180
• Product Code: NIP
• UDI-Device Identifier: 05391526850404
• UDI-Public: (01)05391526850404(17)220715(11)201214(10)0000063197
• 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: 2022
• 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): 07/27/2023

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: 07/15/2022
• Device Catalogue Number: 142122-03
• Device Lot Number: 0000063197
• 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: 06/30/2023
• Initial Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2020
• 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: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White