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

Model Number 144700-12

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

Patient Problems Impaired Healing (2378); Localized Skin Lesion (4542); Restenosis (4576)

Event Date 11/22/2021

Event Type  Injury  

Event 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 bionomics 3d (bm3d) stent ( 6.0 x 150mm stent) to treat a denovo lesion of the sfa middle third to proximal popliteal artery in the left leg.A antegrade approach was used and pre-dilatation and post-dilatation of the target lesion was conducted with percutaneous transluminal angioplasty (pta).Atherectomy was also performed pre stent placement.On the (b)(6) 2022, an event of restenosis of treated segment (target lesion) was reported from the site.It was reported as "not related" to the device and "not related" to the procedure but worsening pre-existing condition.It was also reported as target lesion related.The patient outcome is reported as "resolved/recovered".It led to a target lesion revascularisation and it involved a bm3d stent placement, laser atherectomy, and percutaneous transluminal angioplasty (pta) following updates provided from site on (b)(6) 2022.This intervention took place on (b)(6) 2021.The device remains 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-conformance's 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 is listed in the bionomics 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 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 (6.0 x 150mm stent) to treat a denovo lesion of the superficial femoral artery (sfa) middle third to proximal popliteal artery in the left leg.An antegrade approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) and atherectomy.The lesion was also post-dilated with pta.On the 10-dec-21, the site identified a restenosis of treated segment (target lesion).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 also reported as target lesion related.The patient had a left leg extremity (lle) slowly healing wound.An angiogram and arterial intravascular ultrasound (ivus) were performed.The event led to a target lesion/vessel revascularisation (tlr/tvr) and it involved a bm3d stent placement, laser atherectomy, and pta/standard balloon angioplasty on the sfa ostial to proximal third on 10-dec-21.The patient outcome was reported as "resolved/recovered".The device remains implanted.This was reviewed by veryan on 13-jun-22 and considered possibly related to the device.

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 requiring intervention and 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.

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 requiring intervention and 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.

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 requiring intervention and 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 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 (a 6.0 x 150mm stent) to treat a denovo lesion of the sfa middle third to proximal popliteal artery in the left leg.An antegrade approach was used and the lesion was prepared using pre-dilatation with percutaneous transluminal angioplasty (pta) and laser atherectomy.The treated segment was post-dilated with pta.On (b)(6) 21, an event of restenosis of treated vessel (target vessel) was identified by the site.It was reported as "not related" to the device and "not related" to the procedure but worsening pre-existing condition.It was not target lesion-related.The patient had a slowly healing left leg extremity (lle) wound.A lle angiogram and intravascular ultrasound (ivus) arterial use were performed.A left laser atherectomy and plain old balloon angioplasty (poba) of the proximal sfa (native vessel) and proximal edge of the sfa stent was conducted.There was also laser atherectomy and angioplasty of the left tibioperoneal trunk (tpt).There was a left proximal sfa stent placement.The patient outcome was reported as "resolved/recovered".It led to a target lesion revascularisation (tlr) and it involved a bm3d stent placement, laser atherectomy, and percutaneous transluminal angioplasty (pta) on the sfa ostial to sfa proximal third.This intervention took place on (b)(6) 21.The device remains implanted.Veryan received updated information on this event on (b)(6) 24.

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-conformance's 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 requiring intervention and 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 update to the intervention and that this event is not considered device related, sections g.6.And h.2.Were updated to reflect the type of report (follow-up 04) and the reason, and section h.11.Was updated to reflect the sections where information has changed 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 subject was implanted with one biomimics 3d (bm3d) stent (a 6.0 x 150mm stent) to treat a denovo lesion of the sfa middle third to proximal popliteal artery in the left leg.An antegrade approach was used and the lesion was prepared using pre-dilatation with percutaneous transluminal angioplasty (pta) and laser atherectomy.The treated segment was post-dilated with pta.On 22-nov-2021, an event of restenosis of treated vessel (target vessel) was identified by the site.It was reported as "not related" to the device and "not related" to the procedure but worsening pre-existing condition.It was not target lesion-related.The patient had a slowly healing left lower extremity (lle) wound.A lle angiogram and intravascular ultrasound (ivus) arterial use were performed.A left laser atherectomy and plain old balloon angioplasty (poba) of the proximal sfa (native vessel) and proximal edge of the sfa stent was conducted.There was also laser atherectomy and angioplasty of the left tibioperoneal trunk (tpt).There was a left proximal sfa stent placement.The patient outcome was reported as "resolved/recovered".It did not lead to a target lesion revascularisation (tlr) but it was reported as a target vessel revascularisation (tvr) and it involved a bm3d stent placement, laser atherectomy, and percutaneous transluminal angioplasty (pta) on the sfa ostial to sfa proximal third.This intervention took place on (b)(6) 2021.The device remains implanted.Veryan received updated information on this event on 19-jan-2024.Additional information received from the site and reviewed by veryan on 05-mar-2024 updated the intervention details to reflect that this intervention was not a tlr.As a result, and as it was not target lesion-related, this event was not considered device-related as the restenosis was a separate segment to the segment of an artery that was stented with the bm3d.

• 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: 15056832
• MDR Text Key: 296178749
• Report Number: 3011632150-2022-00056
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850510
• UDI-Public: (01)05391526850510(17)220702(11)201201(10)0000061412
• 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,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2022
• Device Model Number: 144700-12
• Device Catalogue Number: 144700-12
• Device Lot Number: 0000061412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 195 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American