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

Model Number	142122-07
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Restenosis (4576)
Date of Event	05/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to mdr number 3011632150-2023-00086.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 and claudication/leg pain are listed in the biomimics 3d instructions for use and are 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 report is related to mdr number 3011632150-2023-00086.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 (bm3d) stents, a 7.0 x 150 mm stent and a 7.0 x 80 mm stent (the subject of this report) which were used to treat a denovo lesion of the superficial femoral artery (sfa) middle third to proximal popliteal artery in the right leg.A retrograde approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.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 definitely related to the device and not related to the procedure.It was also reported as target lesion related.The patient had a 12-month ankle brachial index (abi) and duplex ultrasound (dus) on the (b)(6) 2022.The abi on the right was measured at 0.37 (resting) and dus showed monophasic waveforms throughout and elevated velocities.The patient was experiencing symptoms consistent with rutherford class 3.A diagnostic angiogram on (b)(6) 2022 identified that the right mid/distal sfa had a 99% target lesion (tl) in-stent restenosis (isr).The percutaneous intervention was conducted on (b)(6) 2022.The patient underwent laser atherectomy and drug coated balloon / drug eluting balloon (dcb/deb) treatment on the sfa distal third.This left less than 10% residual stenosis.The intervention was reported as a target lesion/vessel revascularisation (tlr/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; 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, H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 17279927
• Report Number: 3011632150-2023-00087
• Device Sequence Number: 3534397
• Product Code: NIP
• UDI-Device Identifier: 05391526850435
• UDI-Public: (01)05391526850435(17)220617(11)201116(10)0000058438
• 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): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/07/2023

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: 142122-07
• Device Catalogue Number: 142122-07
• Device Lot Number: 0000058438
• 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: 06/09/2023
• Initial Report FDA Received Date: 07/07/2023
• 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: ELIQUIS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White