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

Catalog Number	142122-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Skin Discoloration (2074); Restenosis (4576)
Date of Event	08/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is related to mdr report 3011632150-2023-00113.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 interventions 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.
Event or Problem Description
This is related to mdr report 3011632150-2023-00113.The patient was treated as part of the mimics 3d usa post-market observational study.On the 22-dec-21, the patient was implanted with two biomimics 3d (bm3d) stents in the right leg, a 5.0 x 150 mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) proximal third to middle third and a 5.0 x 60 mm stent (the subject of this report) to treat a denovo lesion in the sfa middle third to distal third.An antegrade approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon.The treated segment was post-dilated with pta.On (b)(6) 2023, the site identified a restenosis of treated segment (target lesion).It was reported as possibly related to the device and not related to the procedure.It was target lesion related.The patient was seen in the office on (b)(6) 2023 for right foot pain and discoloration.Duplex ultrasound (dus) confirmed a right sfa stent occlusion with reconstitution of the popliteal at the knee level.A right leg angiogram was then scheduled and completed on (b)(6) 2023.A percutaneous intervention was performed and medication was administered.It was reported as a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.The devices remain implanted.
Event or Problem Description
This is related to mdr report 3011632150-2023-00113.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 two biomimics 3d (bm3d) stents in the right leg, a 5.0 x 150 mm stent which was used to treat a restenotic lesion of the superficial femoral artery (sfa) proximal third to middle third and a 5.0 x 60 mm stent (the subject of this report) to treat a restenotic lesion in the sfa middle third to distal third.An antegrade approach was used and the lesions were prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon.The treated segments were post-dilated with pta.On (b)(6) 2023, the site identified a restenosis of treated segment (target lesion).It was reported as possibly related to the device and not related to the procedure.It was target lesion related.The patient was seen in the office on (b)(6) 2023 for right foot pain and discoloration.Duplex ultrasound (dus) confirmed a right sfa stent occlusion with reconstitution of the popliteal at the knee level.A right leg angiogram was then scheduled and completed on (b)(6) 2023.The angiogram showed that there were areas of in-stent restenosis particularly in the mid and distal segments of the stent which were functionally occlusive with only faint filling of the popliteal artery distally.The sfa middle to proximal popliteal artery was treated with laser atherectomy and pta/standard balloon angioplasty with resolution of stenosis post treatment.The peroneal artery was also treated with balloon angioplasty.There was also medication administered as part of the action taken.It was reported as a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.The devices remain implanted.
Additional Manufacturer Narrative
This is related to mdr report 3011632150-2023-00113.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 interventions 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.
Additional Manufacturer Narrative
This is related to mdr report 3011632150-2023-00113.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 interventions 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 change in the date of onset, section b.5.Was updated with the additional information received.
Event or Problem Description
This is related to mdr report 3011632150-2023-00113.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 two biomimics 3d (bm3d) stents in the right leg, a 5.0 x 150 mm stent which was used to treat a restenotic lesion of the superficial femoral artery (sfa) proximal third to middle third and a 5.0 x 60 mm stent (the subject of this report) to treat a restenotic lesion in the sfa middle third to distal third.An antegrade approach was used and the lesions were prepared using pre-dilation with percutaneous transluminal angioplasty (pta).The treated segments were post-dilated with pta.On (b)(6) 2023, the site identified a restenosis of treated segment (target lesion).It was reported as possibly related to the device and not related to the procedure.It was target lesion related.The patient was seen in the office on (b)(6) 2023 for right foot pain and discoloration.Duplex ultrasound (dus) confirmed a right sfa stent occlusion with reconstitution of the popliteal at the knee level.A right leg angiogram was then scheduled and completed on (b)(6) 2023.The angiogram showed that there were areas of in-stent restenosis particularly in the mid and distal segments of the stent which were functionally occlusive with only faint filling of the popliteal artery distally.The sfa middle to proximal popliteal artery was treated with laser atherectomy and pta/standard balloon angioplasty with resolution of stenosis post treatment.The peroneal artery was also treated with balloon angioplasty.There was medication administered as part of the action.It was reported as a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.The devices remain implanted.Additional information was received on (b)(6) 2024 via the site, they updated the date of onset from 09-aug-23 to (b)(6) 2023.This restenosis of treated segment (target lesion) was the third event of this type and as per the clinical events committee (cec) adjudication of similar events, due to the previous tlr interventions which manipulated the vessel this event was not considered related to the device.The initial restenosis was reported as mdr reports 3011632150-2022-00090 and 3011632150-2022-00091 and the second restenosis event was reported as mdr reports 3011632150-2023-00013 and 3011632150-2023-00014.

• 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: 17688746
• Report Number: 3011632150-2023-00114
• Device Sequence Number: 17671297
• Product Code: NIP
• UDI-Device Identifier: 05391526850381
• UDI-Public: (01)05391526850381(17)220813(11)210112(10)0000066597
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 05/08/2024

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: 08/13/2022
• Device Catalogue Number: 142122-01
• Device Lot Number: 0000066597
• 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: 08/10/2023
• Supplement Date Received by Manufacturer: 10/02/2023; 04/09/2024
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 11/01/2023; 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White