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

Catalog Number 142122-14

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

Patient Problems Pain (1994); Restenosis (4576)

Event Date 12/16/2022

Event Type  Injury  

Event Description

This report is related to mdr number 3011632150-2023-00010.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 (the study device), a 6.0 x 150mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) distal third to proximal popliteal artery 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.On the (b)(6) 2022, an event of occlusion (mdr 3011632150-2022-00105) was reported and it was treated with an additional non-study bm3d device (the subject of this report) which was placed in the segment between the sfa proximal third and sfa distal third.The stent details are unknown.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 a right leg extremity (rle) claudication rutherford class 3 (rc 3).A severe in-stent restenosis in the right sfa/popliteal.It was treated with laser atherectomy and pta/standard balloon angioplasty of the sfa proximal third to proximal popliteal artery on the (b)(6) 2022.It was reported as a target lesion/vessel revascularisation (tlr/tvr).This segment included areas of the vessel where both devices were implanted.The patient outcome was reported as resolved/recovered and the devices remain implanted.The details of this event were reviewed originally by veryan on (b)(6) 2023 where it was considered possibly related to the study device.The details of the non-study device were reviewed on (b)(6) 2023 and the event was considered possibly related to both devices.

Manufacturer Narrative

This report is related to mdr number 3011632150-2023-00010.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.

Manufacturer Narrative

This report is related to mdr number 3011632150-2023-00010.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 Description

This report is related to mdr number 3011632150-2023-00010.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 (the study device), a 6.0 x 150mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) distal third to proximal popliteal artery 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.On (b)(6) 2022, an event of occlusion (mdr 3011632150-2022-00105) was reported and it was treated with an additional non-study 6.0 x 125 mm bm3d device (the subject of this report) which was placed in the segment between the sfa proximal third and sfa distal third.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 a right leg extremity (rle) claudication rutherford class 3 (rc 3).A severe in-stent restenosis in the right sfa/popliteal.It was treated with laser atherectomy and pta/standard balloon angioplasty of the sfa proximal third to the proximal popliteal artery on (b)(6) 2022.It was reported as a target lesion/vessel revascularisation (tlr/tvr).This segment included areas of the vessel where both devices were implanted.The patient outcome was reported as resolved/recovered and the devices remain implanted.The details of this event were reviewed originally by veryan on 09-jan-23 where it was considered possibly related to the study device.The details of the non-study device were reviewed on 25-sept-23 and the event was considered possibly related to both devices.Additional information received by the site on 27-feb-24 included the details of the non-study device that was implanted on (b)(6) 2022.

Manufacturer Narrative

This report is related to mdr number 3011632150-2023-00010.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.Section a.1.Was updated to reflect the updated patient identifier, section b.5.Was updated with additional information, sections g.6.And h.2.Were updated with the type of report (follow-up 02) and the reason and section h.11.Was updated to reflect the changed sections in this report.

Event Description

This report is related to mdr number 3011632150-2023-00010.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 (the study device), a 6.0 x 150mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) distal third to proximal popliteal artery 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.On 10-mar-22, an event of occlusion was reported and it was treated with an additional non-study 6.0 x 125 mm bm3d device (the subject of this report) which was placed in the segment between the sfa proximal third and sfa distal third.The site reported that on (b)(6) 2022, a restenosis of treated vessel (target vessel) 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 not target lesion-related and required percutaneous intervention.The patient had a right leg extremity (rle) claudication rutherford class 3 (rc 3).A severe in-stent restenosis in the right sfa/popliteal.It was treated with laser atherectomy and pta/standard balloon angioplasty of the sfa proximal third to the proximal popliteal artery on (b)(6) 2022.It was reported as a target lesion/vessel revascularisation (tlr/tvr).This segment included areas of the vessel where both devices were implanted.The patient outcome was reported as resolved/recovered and the devices remain implanted.The details of this event were reviewed originally by veryan on 09-jan-23 where it was considered possibly related to the study device.The details of the non-study device were reviewed on 25-sept-23 and the event was considered possibly related to both devices.Additional information reviewed on 15-apr-24 included the clinical events committee (cec) determination that this event of restenosis was not related to the study device implanted.This event was the second event that had occurred in the study stent and required a tlr intervention and as a result, this event was determined to be due to the progression of the patient's underlying disease.The first event was an occlusion event that was reported in mdr 3011632150-2022-00105.The restenosis involved the non-study stented segment and this was the first restenosis of this stent so it was still considered possibly related to this event.

• 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: 18001364
• MDR Text Key: 326447519
• Report Number: 3011632150-2023-00129
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850480
• UDI-Public: (01)05391526850480(17)220702(11)201201(10)0000052898
• 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
• Report Date: 05/14/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2022
• Device Catalogue Number: 142122-14
• Device Lot Number: 0000052898
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/25/2023
• Supplement Dates Manufacturer Received: 02/27/2024; 04/15/2024
• Supplement Dates FDA Received: 03/26/2024; 05/14/2024
• 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; CLOPIDOGREL (PLAVIX)
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 234 KG
• Patient Ethnicity: Hispanic