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 Code	Restenosis (4576)
Date of Event	02/07/2022
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 effect of restenosis leading to intervention is listed in the biomimics 3d instructions for use and is a 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 treated as part of the mimics 3d usa post-market observational study on (b)(6) 2021.The subject was implanted with one biomimics 3d (bm3d) stent ( 6.0 x 125mm stent) to treat a denovo lesion of the sfa middle third artery in the left leg.A contralateral approach was used and post-dilatation of the target lesion was conducted with percutaneous transluminal angioplasty (pta) after stent placement and atherectomy was performed pre-stent placement.On (b)(6) 2022, an event of restenosis of treated segment (target lesion) was reported from the site.It was reported with a relationship to the device as "not assessable/unknown" to the device and "not related" to the procedure but due to worsening pre-existing condition.It was also reported as target lesion related.The patient outcome is reported as "resolved/recovered".It led to a percutaneous intervention on (b)(6) 2022 and it involved stent placement (non biomimics), balloon angioplasty and laser atherectomy.The device remains implanted.This was reviewed by veryan on (b)(6) 2022 and considered to be possibly related to the device as it led to a target lesion revascularisation.
Event or Problem Description
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 one biomimics 3d (bm3d) stent in the left leg, a 6.0 x 125 mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) middle third.A contralateral approach was used and the lesion was prepared using atherectomy.The treated segment was post-dilated with percutaneous transluminal angioplasty (pta).The site identified a restenosis of treated segment (target lesion) on (b)(6) 2022.It was reported as not related to the device and not related to the procedure but due to a worsening of the patient's pre-existing condition.It was target lesion related.A percutaneous intervention on (b)(6) 2022 involved non bm3d bare metal stent placement, laser atherectomy and pta/standard balloon angioplasty on the sfa middle third to distal popliteal segment.It was reported as a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.The device remains implanted.The event was reviewed by veryan on 27-jun-22 and considered possibly related to the device.
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 effect of restenosis leading to intervention is listed in the biomimics 3d instructions for use and is a 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.Sections b.5., b.7., d.4., e.1., g.1., g.6., and h.10.Have been updated.Additional information related to this event received on 20-sept-22 updated the device relationship from "not assessable/unknown" to "not related".If any additional information becomes available it will be provided in a mdr supplemental report.
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 effect of restenosis leading to intervention is listed in the biomimics 3d instructions for use and is a 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.Section b.5.Was updated to reflect the updated device relationship, section b.7.Was corrected for clarity, g.6.And h.2.Were updated to reflect the type of report (follow-up 02) and reason, and h.11.Reflects the sections of the report that were updated.
Event or Problem Description
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 one biomimics 3d (bm3d) stent in the left leg, a 6.0 x 125 mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) middle third.A contralateral approach was used and the lesion was prepared using atherectomy.The treated segment was post-dilated with percutaneous transluminal angioplasty (pta).The site identified a restenosis of treated segment (target lesion) on (b)(6) 2022.It was reported as possibly related to the device and not related to the procedure.It was target lesion-related.A percutaneous intervention on (b)(6)2022 involved non-bm3d bare metal stent placement, laser atherectomy and pta/standard balloon angioplasty on the sfa middle third to distal popliteal segment.It was reported as a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.The device remains implanted.The event was reviewed by veryan on 27-jun-22 and considered possibly related to the device.Additional information provided by the site on 01-mar-24 updated the device relationship from not related to possibly 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: 15108727
• Report Number: 3011632150-2022-00064
• Device Sequence Number: 17197098
• Product Code: NIP
• UDI-Device Identifier: 05391526850480
• UDI-Public: (01)05391526850480(17)220307(11)200806(10)0000048380
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2024

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: 03/07/2022
• Device Model Number: 142122-14
• Device Catalogue Number: 142122-14
• Device Lot Number: 0000048380
• 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: 06/27/2022
• Supplement Date Received by Manufacturer: 09/20/2022; 03/01/2024
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 08/04/2023; 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2020
• 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; CLOPIDOGREL (PLAVIX)
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 245 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White