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

Model Number	142122-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	05/26/2023
Type of Reportable Event	Serious Injury
Additional 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 leading to intervention 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 or Problem 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 biomimics 3d (bm3d) stent, a 7.0 x 60 mm stent was used to treat a denovo lesion of the superficial femoral artery (sfa) ostial to proximal third in the left leg.A contralateral approach was used and the lesion was prepared using percutaneous transluminal angioplasty (pta) and atherectomy.The treated segment was post-dilated with pta.The site identified a restenosis of treated segment (target lesion) on (b)(6) 2023.It was reported as not related to the device or procedure but due to a worsening pre-existing condition.An in-stent restenosis (isr) was seen on duplex ultrasound (dus) on (b)(6) 2023.It was also reported as target lesion related.An intervention was performed on (b)(6) 2023.The outcome was reported as resolved/recovered.The device remains implanted.This event was reviewed by veryan and considered possibly related to the device.
Additional Manufacturer Narrative
This is related to mdr number 3011632150-2023-00125.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 leading to intervention 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 or Problem Description
This is related to mdr number 3011632150-2023-00125.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, a 7.0 x 60 mm stent (the subject of this report) was used to treat a denovo lesion of the superficial femoral artery (sfa) ostial to proximal third in the left leg.The patient also had a 6.0 x 100mm bm3d stent placed in the left sfa distal third to proximal popliteal segment on (b)(6) 2022 for a restenosis.A contralateral approach was used and the lesions were prepared using standard percutaneous transluminal angioplasty (pta) and atherectomy.The treated segments were also post-dilated with pta.The site identified a restenosis of treated segment (target lesion) on (b)(6) 2023.It was reported as not related to the device or procedure but due to a worsening pre-existing condition.An in-stent restenosis (isr) was seen on duplex ultrasound (dus) on (b)(6) 2023.It was also reported as target lesion related.An intervention was performed on (b)(6) 2023.This involved drug coated balloon/drug eluting balloon (dcb/deb), pta/standard balloon angioplasty and laser atherectomy of the sfa proximal third to proximal popliteal.It was reported as a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.The devices remain implanted.This event was reviewed by veryan and considered possibly related to the device.
Additional Manufacturer Narrative
This is related to mdr number 3011632150-2023-00125.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 leading to intervention 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 or Problem Description
This is related to mdr number 3011632150-2023-00125.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, a 7.0 x 60 mm stent (the subject of this report) was used to treat a denovo lesion of the superficial femoral artery (sfa) ostial to proximal third in the left leg.The patient also had a 6.0 x 100mm bm3d stent placed in the left sfa distal third to proximal popliteal segment on (b)(6) 2022 for a restenosis.A second non-study commercial bm3d 7.0 x 150 mm stent was implanted in this patient on (b)(6) 2022 for a restenosis event in the sfa middle third.A contralateral approach was used and the lesions were prepared using standard percutaneous transluminal angioplasty (pta) and atherectomy.The treated segments were also post-dilated with pta.The site identified a restenosis of treated segment (target lesion) on (b)(6) 2023.It was reported as not related to the device or procedure but due to a worsening pre-existing condition.An in-stent restenosis (isr) was seen on duplex ultrasound (dus) on (b)(6) 2023.It was also reported as target lesion related.An intervention was performed on (b)(6) 2023.This involved drug coated balloon / drug eluting balloon (dcb/deb), pta/standard balloon angioplasty and laser atherectomy of the sfa proximal third to proximal popliteal.It was reported as a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.The devices remain implanted.This event was reviewed by veryan and considered possibly related to the device.Additional information received from the site and reviewed by veryan on 05-mar-24, reported the second non-study commercial 7.0 x 150 mm stent that was implanted.This event was the fourth restenosis of the study stent and the second restenosis of the non-study stents and as a result these events would not be considered device related due to the previous multiple interventions that have been performed on the vessel.This reflects the clinical events committee (cec) adjudications of similar events.

• 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: 17343731
• Report Number: 3011632150-2023-00090
• Device Sequence Number: 6894174
• Product Code: NIP
• UDI-Device Identifier: 05391526850404
• UDI-Public: (01)05391526850404(17)220523(11)201022(10)0000056142
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/03/2024

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: 05/23/2022
• Device Model Number: 142122-03
• Device Catalogue Number: 142122-03
• Device Lot Number: 0000056142
• 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: 06/19/2023
• Supplement Date Received by Manufacturer: 09/13/2023; 03/05/2024
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 10/12/2023; 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN; CLOPIDOGREL (PLAVIX)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 189 KG
• Patient Ethnicity: Hispanic