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

Model Number 142122-02

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

Patient Problems Discomfort (2330); Restenosis (4576)

Event Date 01/18/2023

Event Type  Injury  

Manufacturer Narrative

This is related to mdr number 3011632150-2023-00032.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/discomfort is 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 is related to mdr number 3011632150-2023-00032.The patient was treated as part of the mimics 3d usa post-market observational study.On the (b)(6) 2022, the patient was implanted with two biomimics 3d (bm3d) stents, a 6.0 x 60mm stent (the subject of this report) was used to treat a denovo lesion of the superficial femoral artery (sfa) proximal third to middle third segment and a 6.0 x 100mm stent was used to treat a denovo lesion in the sfa middle third to distal third in the right leg.A retrograde approach was used and the lesions were prepared using atherectomy and pre-dilated with percutaneous transluminal angioplasty (pta).The treated segments were 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 possibly related to the device and not related to the procedure.It was reported as target lesion related.The patient attended the clinic on (b)(6)2023 for recurrent discomfort in the right leg.An ultrasound showed a likely in-stent restenosis.An endovascular procedure was conducted on (b)(6)2023.There was a high-grade stenosis measuring 66.9% just proximal to the proximal right sfa stent.There were multiple critical stenoses present throughout the sfa to distal popliteal arterial segment.A laser atherectomy was performed along the length of the sfa and popliteal artery and tibioperoneal trunk (tpt).Two pta/standard balloons were used for angioplasty within the entire diseased area.The completion imaging revealed focal areas of dissection in the proximal sfa located distally to the previously placed stent and within the proximal popliteal artery located distally to the previously placed popliteal stent.A 5.0 x 60mm bm3d stent was placed into the sfa distal third to distal popliteal arterial segment as a bail-out after balloon angioplasty and an everflex stent was placed in the proximal sfa.Following the treatments, completion imaging revealed wide patency of the treated areas.It was reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).Veryan's chief medical officer (cmo) reviewed the information and concluded that the dissections occurred after laser atherectomy and balloon angioplasty in the native arteries above and below the stents during the intervention procedure.The dissections are a well-recognised complication of angioplasty and were not related to the bm3d stents.The patient outcome was reported as resolved/recovered and the devices remain implanted.

Event Description

This is related to mdr number 3011632150-2023-00032.The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6) 2022, the patient was implanted with two biomimics 3d (bm3d) stents, a 6.0 x 60 mm stent (the subject of this report) was used to treat a denovo lesion of the superficial femoral artery (sfa) proximal third to middle third segment and a 6.0 x 100 mm bm3d stent was used to treat a denovo lesion in the sfa middle third to distal third in the right leg.A retrograde approach was used and the lesions were prepared using atherectomy and pre-dilated with percutaneous transluminal angioplasty (pta).The treated segments were also post-dilated with pta.The site reported that on 18-jan-23, a restenosis of treated segment (target lesion) was identified.It was reported as possibly related to the device and not related to the procedure.It was reported as target lesion-related.The patient attended the clinic on (b)(6) 2023 for recurrent discomfort in the right leg.An ultrasound showed a likely in-stent restenosis.An endovascular procedure was conducted on (b)(6) 2023.There was a high-grade stenosis measuring 66.9% just proximal to the proximal right sfa stent.There were multiple critical stenoses present throughout the sfa to distal popliteal arterial segment.A laser atherectomy was performed along the length of the sfa and popliteal artery and tibial-peroneal trunk (tpt).Two pta/standard balloons were used for angioplasty within the entire diseased area.The completion imaging revealed focal areas of dissection in the proximal sfa located distally to the previously placed stent and within the proximal popliteal artery located distally to the previously placed popliteal stent.A 5.0 x 60 mm bm3d stent was placed into the sfa distal third to distal popliteal arterial segment as a bail-out after balloon angioplasty and an everflex stent was placed in the proximal sfa.Following the treatments, completion imaging revealed wide patency of the treated areas.It was reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).The dissections occurred after laser atherectomy and balloon angioplasty in the native arteries above and below the stents during the intervention procedure.The dissections are a well-recognised complication of angioplasty and were not related to the bm3d stents.The patient outcome was reported as resolved/recovered and the devices remain implanted.Veryan reviewed this event on 02-apr-24, and the adjudication of the event by the clinical events committee (cec).It was adjudicated as unrelated to the study devices as this was the second restenosis of treated segment (target lesion) treated with tlr and as a result of the previous manipulations in the vessel segment as part of the previous tlr intervention.The first restenosis of the treated segment (target lesion) was reported as mdr reports 3011632150-2022-00096 and 3011632150-2022-00097.

Manufacturer Narrative

This is related to mdr number 3011632150-2023-00032.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/discomfort is 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 the additional information received.Section b.7.Was updated to reflect the procedure conducted prior to the bm3d implantation, section d.10.Was updated to reflect the changes to the patient's concomitant medication, sections d.3.And g.1.Were updated to reflect veryan's new address details which have changed since the submission of the initial reports.Sections g.6.And h.2.Were updated to reflect the type of the report (follow-up 01) and the reason, and section h.11.Was updated to reflect the sections of this report that have changed.

• 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: 16516351
• MDR Text Key: 311043461
• Report Number: 3011632150-2023-00031
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850398
• UDI-Public: (01)05391526850398(17)230605(11)211104(10)0000118074
• 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
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2023
• Device Model Number: 142122-02
• Device Catalogue Number: 142122-02
• Device Lot Number: 0000118074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• 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; CLOPIDOGREL (PLAVIX); XARELTO
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White