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

Model Number	142122-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Pain (1994); Skin Discoloration (2074); Restenosis (4576)
Date of Event	02/13/2023
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 ischemia, restenosis and claudication/leg pain leading to intervention 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 implanted with one biomimics 3d (bm3d) stent, a 6.0 x 125mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) middle third 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 site identified a restenosis of treated segment (target lesion) on (b)(6) 2023.It was reported as definitely related to the device and not related to the procedure.It was target lesion related.The patient was seen in clinic on (b)(6) 2023 complaining of leg pain at rest.Clinical symptoms included no pulse in right leg, skin was cool to touch, and there was discoloration of the shin reported as ischemia which was possibly related to the device.A diagnostic angiogram was performed on (b)(6) 2023 which showed the right profundus was totally occluded, the mid-sfa stent (target) was 99% stenosed, the popliteal artery was 90% stenosed, and the mid and proximal section of the posterior tibial (pt) artery was stenosed.On (b)(6) 2023, the patient underwent an intervention on the right leg.This involved laser atherectomy in the pta as well as proximal/mid/distal sfa.Pta/standard balloon angioplasty was also performed in the pta and mid sfa.In the proximal segment of the target stent (mid sfa) there was a flow limiting dissection and suboptimal results in the proximal sfa.Two bare metal competitor stents: a 6 x 120mm stent and a 6 x 60mm stent were overlapped with the previously placed stent in the proximal sfa.Both stents were post-dilated with plain old balloon catheter (pobc).The details of the dissection were reviewed by veryan's cmo who considered it a complication of the interventions performed (pta and atherectomy) as dissections cannot occur in stented regions.The intervention was reported as a target lesion/vessel revascularisation (tlr/tvr).The patient outcome was reported as resolved/recovered and the device remains 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, H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 17191821
• Report Number: 3011632150-2023-00073
• Device Sequence Number: 5754651
• Product Code: NIP
• UDI-Device Identifier: 05391526850480
• UDI-Public: (01)05391526850480(17)230929(11)220228(10)0000136622
• 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: 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): 06/23/2023

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: 09/29/2023
• Device Model Number: 142122-14
• Device Catalogue Number: 142122-14
• Device Lot Number: 0000136622
• 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: 05/27/2023
• Initial Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2022
• 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: CLOPIDOGREL (PLAVIX); ELIQUIS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White