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

Catalog Number 142122-06

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Impaired Healing (2378); Restenosis (4576)

Event Date 05/26/2023

Event Type  Injury  

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, leg pain/claudication and vascular complications which may require surgical repair (conversion to open surgery) or endovascular intervention; worsening of peripheral arterial disease leading to additional surgical intervention, endovascular intervention or amputation 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 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 6.0 x 150 mm biomimics 3d (bm3d) stent (the study stent) in the sfa middle third to proximal popliteal segment in the left leg.On (b)(6) 2021, the site identified a restenosis of treated segment (target lesion) (mdr number 3011632150-2022-00056) and an additional non-study 6.0 x 80 mm bm3d stent (the subject of this report) was placed in the sfa ostial to sfa proximal third to treat a denovo lesion in the left leg.A contralateral approach was used, and the lesion was prepared using percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was also post-dilated with pta.The site identified a restenosis on (b)(6) 2023.It was not related to the study device or study procedure but was due to an intercurrent condition.The patient had left lower extremity (lle) pain and a slowly healing wound to the lle.Duplex ultrasound (dus) on (b)(6) 2023 showed severe stenosis of the profunda femoris artery (pfa), common femoral artery (cfa) and sfa.The left ostial sfa and pfa were successfully revascularised.The event outcome was reported as resolved/recovered.The event was reviewed by veryan on (b)(6) 2023 and considered possibly related to the 6.0 x 80 mm non-study bm3d device.The devices remain implanted.

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, leg pain/claudication and vascular complications which may require surgical repair (conversion to open surgery) or endovascular intervention; worsening of peripheral arterial disease leading to additional surgical intervention, endovascular intervention or amputation 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.3., b.5., g.6.And h.11.Have been updated.

Event 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 6.0 x 150 mm biomimics 3d (bm3d) stent (the study stent) in the sfa middle third to proximal popliteal segment in the left leg.On (b)(6) 2021, the site identified a restenosis of treated segment (target lesion) (mdr number 3011632150-2022-00056) and an additional non-study 6.0 x 80 mm bm3d stent (the subject of this report) was placed in the sfa ostial to sfa proximal third to treat a denovo lesion in the left leg.A contralateral approach was used, and the lesion was prepared using percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was also post-dilated with pta.The site identified a restenosis of treated vessel (target vessel) on (b)(6) 2023.It was not related to the study device or study procedure but was due to a worsening pre-existing condition.The patient had left lower extremity (lle) pain and a slowly healing wound to the lle.Duplex ultrasound (dus) on (b)(6) 2023 showed severe stenosis of the profunda femoris artery (pfa), common femoral artery (cfa) and sfa.The left ostial sfa and pfa were successfully revascularised on (b)(6) 2023.Laser atherectomy and pta/standard balloon angioplasty were performed on the sfa ostial segment.This was reported as a target vessel revascularisation (tvr).The event outcome was reported as resolved/recovered.The event was reviewed by veryan on (b)(6) 2023 and considered possibly related to the 6.0 x 80 mm non-study bm3d device.The devices remain implanted.Veryan received additional information in relation to this event on (b)(6) 2024.

Event 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 6.0 x 150 mm biomimics 3d (bm3d) stent (the study stent) in the sfa middle third to proximal popliteal segment in the left leg.On (b)(6) 2021, the site identified a restenosis of treated segment (target lesion) (mdr number 3011632150-2022-00056) and an additional non-study 6.0 x 80 mm bm3d stent (the subject of this report) was placed in the sfa ostial to sfa proximal third to treat a denovo lesion in the left leg.A contralateral approach was used, and the lesion was prepared using percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was also post-dilated with pta.The site identified a restenosis of treated segment (target lesion) on (b)(6) 2023.It was not related to the study device or study procedure but was due to a worsening pre-existing condition.The patient had left lower extremity (lle) pain and a slowly healing wound to the lle.Duplex ultrasound (dus) on (b)(6) 2023 showed severe stenosis of the profunda femoris artery (pfa), common femoral artery (cfa) and sfa.The left ostial sfa and pfa were successfully revascularised on (b)(6) 2023.Laser atherectomy and pta/standard balloon angioplasty were performed on the sfa ostial segment.This was reported as a target vessel revascularisation (tvr).The event outcome was reported as resolved/recovered.The event was reviewed by veryan on 25-sep-23 and considered possibly related to the 6.0 x 80 mm non-study bm3d device.The devices remain implanted.Veryan received additional information in relation to this event on 19-jan-24.Additional information was provided by the site on 27-feb-24 updating this event from a restenosis of treated vessel (target vessel) to a restenosis of treated segment (target lesion).

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, leg pain/claudication and vascular complications which may require surgical repair (conversion to open surgery) or endovascular intervention; worsening of peripheral arterial disease leading to additional surgical intervention, endovascular intervention or amputation 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 to reflect that the event description was updated, g.6.And h.2.Reflect the type of report (follow-up 02) and h.11.Reflects the sections updated on this report.

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, leg pain/claudication and vascular complications which may require surgical repair (conversion to open surgery) or endovascular intervention; worsening of peripheral arterial disease leading to additional surgical intervention, endovascular intervention or amputation 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 to reflect that the event description that was changed, sections g.6.And h.2.Reflect the type of report (follow-up 03) and the reason, and section h.11.Reflects the sections updated on this report.

Event 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 6.0 x 150 mm biomimics 3d (bm3d) stent (the study stent) in the superficial femoral artery (sfa) middle third to proximal popliteal segment in the left leg.On (b)(6) 2021, the site identified a restenosis (mdr number 3011632150-2022-00056) and on (b)(6) 2021 as part of the intervention for this restenosis, an additional non-study 6.0 x 80 mm bm3d stent (the subject of this report) was placed in the sfa ostial to sfa proximal third to treat a denovo lesion in the left leg.A contralateral approach was used, and the lesion was prepared using a percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was also post-dilated with pta.The site identified a restenosis of treated vessel (target vessel) on (b)(6) 2023.It was not related to the study device or study procedure but was due to a worsening pre-existing condition.The patient had left lower extremity (lle) pain and a slowly healing wound to the lle.Duplex ultrasound (dus) on (b)(6) 2023 showed severe stenosis of the profunda femoris artery (pfa), common femoral artery (cfa) and sfa.The left ostial sfa and pfa were successfully revascularised on (b)(6) 2023.Laser atherectomy and pta/standard balloon angioplasty were performed on the sfa ostial segment.This was reported as a target vessel revascularisation (tvr).The event outcome was reported as resolved/recovered.The event was reviewed by veryan on (b)(6) 2023 and considered possibly related to the 6.0 x 80 mm non-study bm3d device.The devices remain implanted.Additional information was provided by the site on (b)(6) 2024 updating this event from a restenosis of treated segment (target lesion) to restenosis of treated vessel (target vessel).

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Type of Device: 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: 18002443
• MDR Text Key: 326466422
• Report Number: 3011632150-2023-00128
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850428
• UDI-Public: (01)05391526850428(17)230211(11)210713(10)0000096641
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2023
• Device Catalogue Number: 142122-06
• Device Lot Number: 0000096641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ASPIRIN
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 195 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American