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

Catalog Number	144700-19
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Restenosis (4576)
Date of Event	07/11/2023
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 and leg pain/claudication 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 7.0 x 150 mm biomimics 3d (bm3d) stent, which was used to treat a denovo lesion of the superficial femoral artery (sfa) middle third to distal third in the left leg.A contralateral approach was used and the lesion was prepared with cuttting balloon pre-stent placement.The treated segment was post-dilated with percutaneous transluminal angioplasty (pta).The site reported that on (b)(6) 2023, a restenosis of treated segment (target lesion) was identified.It was reported as not related to the device and not related to the procedure but due to a worsening pre-existing condition.It was target lesion related.The patient had worsening claudication in the left leg.A computed tomography (ct) scan showed a left sfa with in-stent restenosis (isr).The patient had rutherford class 3 symptoms.It was treated with peripheral intervention to the left sfa.The left sfa had restenosis up to 90% at the proximal edge of the previously placed stent in the mid sfa with additional isr up 90% in the distal portion of this stent (distal sfa).This entire region (sfa middle third to sfa distal third) was treated with drug coated balloon (dcb).There was 0% residual narrowing and no complications.It was reported as a target vessel revascularisation (tvr) and not a target lesion revascularisation (tlr).The outcome was reported as resolved/recovered.The device remains implanted.Veryan's date of awareness of this information was 28-may-24.
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 7.0 x 150 mm biomimics 3d (bm3d) stent, which was used to treat a denovo lesion of the superficial femoral artery (sfa) middle third to distal third in the left leg.A contralateral approach was used and the lesion was prepared with cuttting balloon pre-stent placement.The treated segment was post-dilated with percutaneous transluminal angioplasty (pta).The site reported that on (b)(6)2023, a restenosis of treated segment (target lesion) was identified.It was reported as not related to the device and not related to the procedure but due to a worsening pre-existing condition.It was target lesion related.The patient had worsening claudication in the left leg.A computed tomography (ct) scan showed a left sfa with in-stent restenosis (isr).The patient had rutherford class 3 symptoms.It was treated with peripheral intervention to the left sfa.The left sfa had restenosis up to 90% at the proximal edge of the previously placed stent in the mid sfa with additional isr up 90% in the distal portion of this stent (distal sfa).This entire region (sfa middle third to sfa distal third) was treated with drug coated balloon (dcb).There was 0% residual narrowing and no complications.It was reported as a target vessel revascularisation (tvr) and not a target lesion revascularisation (tlr).The outcome was reported as resolved/recovered.The device remains implanted.Veryan's date of awareness of this information was 28-may-2024.The clinical events committee (cec) adjudications were reviewed at the safety monitoring review (smr) on (b)(6)2025.This event was determined to be related to the device.This information requires an mdr supplemental report.
Additional Manufacturer Narrative
The clinical events committee (cec) adjudications were reviewed at the safety monitoring review (smr) on (b)(6)2025.This event was determined to be related to the device.This information requires an mdr supplemental report.Section b.5.Was updated with additional information received, section g3 was updated, sections g.6.And h.2.Were updated to reflect the report type (follow-up 01) and reason, and section h.11.Was updated to reflect the sections changed in this report.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Common Device Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL; 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: 19593299
• Report Number: 3011632150-2024-00029
• Device Sequence Number: 8470842
• Product Code: NIP
• UDI-Device Identifier: 05391526850527
• UDI-Public: (01)05391526850527(17)230812(11)220111(10)0000128359
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: 08/12/2023
• Device Catalogue Number: 144700-19
• Device Lot Number: 0000128359
• 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: 05/28/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White