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

Model Number	142122-06
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is related to mdr number 3011632150-2023-00024.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 occlusion 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.
Event or Problem Description
This is related to mdr number 3011632150-2023-00024.The patient was treated as part of the mimics 3d usa post-market observational study.On the (b)(6) 2021, the patient was implanted with two biomimics 3d stents (bm3d), a 5.0 x 150mm stent and a 6.0 x 80mm (the subject of this report) stent to treat a restenotic lesion in the superficial femoral artery (sfa) ostial to distal third in the right leg.A contralateral approach was used and the lesion was prepared using atherectomy and pre-dilated with percutaneous transluminal angioplasty (pta).The treated segment was post-dilated with pta.The site reported that on (b)(6) 2022, an occlusion was identified.It was reported as not related to the device and not related to the procedure but due to a worsening of the pre-existing condition.It was reported as target lesion related.The patient presented for an ultrasound on the (b)(6) 2022, which revealed an occluded sfa but the patient stated that she was relatively asymptomatic.The physician decided at the time to repeat the examination in 6 months and no intervention was planned.On (b)(6) 2022 an intervention was conducted which involved pta / standard balloon angioplasty and laser atherectomy on the sfa ostial to distal third segment.The intervention was reported as a target lesion revascularisation (tlr) and a target vessel revascularisation (tvr).The outcome was reported as resolved/recovered.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, H91VE 0H; EI H91VE0H
• Manufacturer Contact: alan mcdonagh ; unit 11 galway technology park; parkmore road; galway, H91VE-0H ; EI H91VE0H
• MDR Report Key: 16426166
• Report Number: 3011632150-2023-00025
• Device Sequence Number: 15150248
• Product Code: NIP
• UDI-Device Identifier: 05391526850428
• UDI-Public: (01)05391526850428(17)220409(11)200908(10)0000051495
• 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): 02/23/2023

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: 04/09/2022
• Device Model Number: 142122-06
• Device Catalogue Number: 142122-06
• Device Lot Number: 0000051495
• 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: 01/27/2023
• Initial Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2020
• 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: CLOPIDOGREL (PLAVIX)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American