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

Catalog Number	142122-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Restenosis (4576)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is related to mdr reports 3011632150-2023-00120 and 3011632150-2023-00121.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 three biomimics 3d (bm3d) stents in the right leg, two 6.0 x 150 mm stents and one 6.0 x 125 mm (the subject of this report) stent were used to treat a denovo lesion of the superficial femoral artery (sfa) proximal third to distal third.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) 2021.It was reported as possibly related to the study device and not related to the study procedure.It was target lesion related.A post-procedural duplex ultrasound (dus) on (b)(6) 2021 showed severe arterial occlusive disease in the right common femoral artery (cfa) and moderate stenosis in the right sfa stent.There was no intervention conducted at the time.At the patient's 24-month dus on (b)(6) 2022, elevated velocities consistent with stenosis in the right cfa and proximal sfa stent were identified.Ankle brachial index (abi) on (b)(6) 2022 showed that the resting right leg value had decreased from 0.94 (a reading taken on (b)(6) 2021 at the patient's 30-day follow-up) to 0.60.A diagnostic angiogram was performed on (b)(6) 2022 which noted rutherford class (rc) 3-4 symptoms.The imaging showed right cfa through to the ostial sfa to be severely diseased and heavily calcified.The right sfa stent was noted to be patent with mild to moderate in-stent restenosis (isr).The patient was referred for vascular surgery for femoral endarterectomy which was performed on (b)(6) 2022.The patient was referred back to the interventional team for further treatment due to continuing rc 3-4 symptoms.On (b)(6) 2023 another diagnostic angiogram was performed which showed the right ostial sfa lesion that extended in to the proximal sfa stent to be 99% stenosed.On (b)(6) 2023, the intervention included laser atherectomy followed by drug coated/eluting balloon (dcb/deb) of the ostial sfa to sfa proximal third.This was reported as a target lesion/vessel revascularisation (tlr/tvr).The stenosis was reduced to 30%.During the same intervention an 80% stenosed lesion in the right external iliac was also discovered.This was treated with a 8.0 x 60mm competitor stent which was placed from external iliac to proximal cfa and then post-dilated by pta.This resolved all claudication symptoms.The outcome was reported as resolved/recovered.The devices remain implanted.
Additional Manufacturer Narrative
This report is related to mdr reports 3011632150-2023-00120 and 3011632150-2023-00121.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 interventions and leg pain/claudication 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.

• 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: 17865102
• Report Number: 3011632150-2023-00122
• Device Sequence Number: 12188771
• Product Code: NIP
• UDI-Device Identifier: 05391526850480
• UDI-Public: (01)05391526850480(17)220329(11)200828(10)0000050212
• 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): 10/03/2023

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: 03/29/2022
• Device Catalogue Number: 142122-14
• Device Lot Number: 0000050212
• 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: 09/07/2023
• Initial Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2020
• 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; CILOSTAZOL (PLETAL); CLOPIDOGREL (PLAVIX)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White