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

Model Number	142122-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Restenosis (4576)
Date of Event	11/08/2022
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 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 and claudication pain are 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
The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6) 2022, the patient was treated with one 6.0 x 60mm biomimics 3d (bm3d) stent to treat a denovo lesion of the proximal popliteal artery 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 lesion was also post-dilated with pta.The site reported that on (b)(6) 2022, a restenosis of the treated segment (target lesion) was identified.The patient attended clinic with increased claudication symptoms in the right lower extremity on (b)(6) 2022.An ultrasound showed in stent stenosis and 50-75% stenosis throughout other parts of the vessel.An angiogram was done on (b)(6) 2022 which showed several areas of in stent stenosis with intimal hyperplasia in both proximal and distal stent (worse in the proximal stent).The popliteal artery was severely diseased with an occlusion in the p2 segment.The intervention on (b)(6) 2022 consisted of pta/standard balloon angioplasty and laser atherectomy on the common femoral artery to the distal third posterior tibial artery and was reported as a target lesion and target vessel revascularisation (tlr/tvr).Repeat angiography demonstrated significant improvement in flow through the treated segments.The restenosis was reported as possibly related to the device and not related to the procedure.It was target lesion related.The device remains implanted.The event is reported as resolved/recovered.

• 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, H91 V E0H; EI H91 VE0H
• Manufacturer Contact: alan mcdonagh ; unit 11 galway technology park; parkmore road; galway, H91VE-0H ; EI H91VE0H
• MDR Report Key: 15978865
• Report Number: 3011632150-2022-00117
• Device Sequence Number: 17882543
• Product Code: NIP
• UDI-Device Identifier: 05391526850398
• UDI-Public: (01)05391526850398(17)230605(11)211104(10)0000118074
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 12/14/2022

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: 06/05/2023
• Device Model Number: 142122-02
• Device Catalogue Number: 142122-02
• Device Lot Number: 0000118074
• 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: 11/23/2022
• Initial Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• 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
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White