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); Ulcer (2274); Impaired Healing (2378); Restenosis (4576)
Date of Event	06/22/2023
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, claudication/leg pain, worsening of peripheral arterial disease leading to additional surgical intervention and serious injury requiring surgical intervention 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
The patient was enrolled in the mimics 3d usa post-market observational study.On (b)(6) 2022, the patient was implanted with one biomimics 3d (bm3d) 6.0 x 125 mm stent to treat a denovo lesion in the right superficial femoral artery (sfa) middle third to the proximal popliteal segment.An antegrade approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) and atherectomy.The treated segment was post-dilated with pta.On 22-jun-23, a restenosis of the treated segment (target lesion) was identified and it was reported as not related to the device and not related to the procedure but was due to a worsening pre-existing condition.It was target lesion-related.The patient had their 12-month follow-up visit on 22-jun-23 where duplex ultrasound (dus) was performed.The patient had an unscheduled clinic visit on 08-mar-24 and rutherford class (rc) 5 symptoms were reported: non-healing ulceration and rest pain.Previous imaging had demonstrated re-occlusion of his right sfa as well as single vessel runoff via the posterior tibial (pt) artery.There was known absent right toe pressures.The patient was lost to follow-up in december, but presented with new non-healing ulcerations and rest pain.These findings were reviewed with the patient and he stated the physician knew of the ulcerations and that he was fine to travel abroad as long as he had a physician there to provide care.Unfortunately with his rest pain and gangrene the patient needed an emergent angiogram to restore blood flow and to help with healing of the wounds.The physician participated in the visit and assisted with bedside ultrasound (us).The patient's arterial disease in his right lower leg was described as severe and continued to progress and was likely due to the patient's underlying diabetes and continued smoking habits.The physician discussed the importance of protecting his feet as his right toe pressures would not facilitate proper wound healing.Previous imaging of the non-study left lower extremity (lle) demonstrated a distally occluded anterior tibial (at) artery with borderline toe pressures.The physician planned to see the patient back emergently for an angiogram procedure prior to him going abroad.The importance of protecting his feet was reiterated as well as the importance of tight glycemic control, attending any related follow-up appointments and taking his medicines as prescribed.The patient verbalised understanding.The physician assisted in setting up a rescheduled podiatry/wound care appointment.The patient had no further questions.The event was treated on 14-mar-24 with percutaneous intervention.A second bm3d non-study stent was placed in the sfa proximal third for a denovo lesion.It was prepared with pta pre-dilation and atherectomy and the treated segment was post-dilated with pta.Pta/standard balloon angioplasty and laser atherectomy were also performed on the sfa proximal third to pt distal third.It was reported as a target lesion/vessel revascularisation (tlr/tvr).The outcome of the event was reported as resolved/recovered.The device remains implanted.This event was reviewed by veryan on 19-mar-24 and considered possibly device-related.

• 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: 19127033
• Report Number: 3011632150-2024-00022
• Device Sequence Number: 8283754
• Product Code: NIP
• UDI-Device Identifier: 05391526850480
• UDI-Public: (01)05391526850480(17)230811(11)220110(10)0000128387
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/17/2024

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: 08/11/2023
• Device Catalogue Number: 142122-14
• Device Lot Number: 0000128387
• 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: 03/19/2024
• Initial Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2022
• 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; ATORVASTATIN; CILOSTAZOL (PLETAL)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American