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

Model 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	12/07/2022
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 the (b)(6) 2021 the patient was implanted with one biomimics 3d (bm3d) stent, a 7.0 x 150mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) middle third to distal third in the right leg.A contralateral approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was also post dilated with 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 reported as target lesion related and required percutaneous intervention.The patient had a right leg extremity angiogram and intervention that involved laser atherectomy and pta/plain old balloon angioplasty (poba) of the distal third of the sfa/proximal popliteal (pop) stent on the (b)(6) 2023.It was reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).The patient outcome was reported as resolved/recovered and the device remains implanted.It was reviewed by veryan and considered possibly related to the device.
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, a 7.0 x 150mm stent which was used to treat a restenotic lesion of the superficial femoral artery (sfa) middle third to distal third in the right leg.A contralateral approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was also post dilated with pta.The site reported that on (b)(6) 23, 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 reported as target lesion related and required percutaneous intervention.The patient had right leg extremity (rle) claudication and a right sfa in-stent restenosis (isr) which was identified on angiogram on (b)(6) 2022.A rle angiogram was performed with an intervention that involved laser atherectomy and pta/standard balloon angioplasty/plain old balloon angioplasty (poba) of the distal half of the sfa/popliteal (pop) stent on the (b)(6) 2023.It was reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).The patient outcome was reported as resolved/recovered and the device remains implanted.It was reviewed by veryan 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 effects of restenosis leading to intervention and claudication/leg 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.Sections b.5., g.6., h.6.And h.10.Have been updated.
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/leg 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.Section b.3.Was updated to reflect the 07-dec-22, section b.5.Was updated with details of the intervention, section d.3.And g.1.Were updated with the veryan address, sections g.6.And h.2.Were updated to reflect the type of report (follow-up 02) and the reason and h.11.Outlines the sections updated.
Event or Problem Description
The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6) 2021, the patient was implanted with one biomimics 3d (bm3d) stent, a 7.0 x 150mm stent which was used to treat a restenotic lesion of the superficial femoral artery (sfa) middle third to distal third in the right leg.A contralateral approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was also post-dilated with pta.The site reported that on (b)(6) 2022, 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 reported as target lesion-related and required percutaneous intervention.The patient had right lower extremity (rle) claudication and a right sfa in-stent restenosis (isr) which was identified on an angiogram on (b)(6) 2022.A rle angiogram was performed with an intervention that involved laser atherectomy and pta/standard balloon angioplasty/plain old balloon angioplasty (poba) of the distal half of the mid to distal sfa/popliteal (pop) stent on the 18-jan-23.Tibioperoneal trunk (tpt) laser atherectomy and poba were also performed.The segment that was treated in the intervention involved the sfa distal third to tpt.It was reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).The patient outcome was reported as resolved/recovered and the device remains implanted.It was reviewed by veryan and considered possibly related to the device.Additional information provided by the site on 27-feb-24, 28-feb-24 and 01-mar-24 added details of the intervention and updated the date of onset from 18-jan-23 to 07-dec-22.
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/leg 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.Section b.5.Was updated with details of the intervention, sections g.6.And h.2.Were updated to reflect the type of report (follow-up 03) and the reason and h.11.Outlines the sections in this report that were updated.
Event or Problem Description
The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6) 2021, the patient was implanted with one biomimics 3d (bm3d) stent, a 7.0 x 150mm stent which was used to treat a restenotic lesion of the superficial femoral artery (sfa) middle third to distal third in the right leg.A contralateral approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was also post-dilated with pta.The site reported that on (b)(6) 2022, 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 reported as target lesion-related and required percutaneous intervention.The patient had right lower extremity (rle) claudication and a right sfa in-stent restenosis (isr) which was identified on an angiogram on (b)(6) 2022.A rle angiogram was performed with an intervention that involved laser atherectomy and pta/standard balloon angioplasty/plain old balloon angioplasty (poba) of the distal half of the mid to distal sfa/popliteal (pop) stent on the (b)(6) 2023.Tibioperoneal trunk (tpt) laser atherectomy and poba were also performed.The segment that was treated in the intervention involved the sfa distal third to tpt.It was reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).The patient outcome was reported as resolved/recovered and the device remains implanted.It was reviewed by veryan and considered possibly related to the device.Additional information reviewed by veryan on 13-may-24 included the clinical events committee (cec) adjudication of this event which determined that this was not related to the devices implanted.This event was the second such event of restenosis in the treated segment that required a tlr.As the segment had already been repeatedly manipulated as part of previous target lesion revascularisation (tlr) intervention, the relationship was most likely due to progression of the disease.The previous restenosis event was reported in mdr report 3011632150-2024-00014.

• 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: 16916501
• Report Number: 3011632150-2023-00062
• Device Sequence Number: 7008396
• Product Code: NIP
• UDI-Device Identifier: 05391526850527
• UDI-Public: (01)05391526850527(17)220611(11)201110(10)0000056112
• 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,Followup
• Report Date (Section B): 06/11/2024

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: 06/11/2022
• Device Model Number: 144700-19
• Device Catalogue Number: 144700-19
• Device Lot Number: 0000056112
• 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: 04/13/2023
• Supplement Date Received by Manufacturer: 06/14/2023; 02/27/2024; 05/13/2024
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 07/14/2023; 03/23/2024; 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• 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; CILOSTAZOL (PLETAL); CLOPIDOGREL (PLAVIX)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 159 KG
• Patient Ethnicity: Hispanic