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

Model Number	144700-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	11/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This event is related to mdr report number 3011632150-2023-00056.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 one biomimics 3d (bm3d) stent, a 6.0 x 150mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) middle third to distal third in the right leg.A retrograde 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.The site reported that on (b)(6) 2022, a restenosis of treated segment (target lesion) was identified.It was reported as definitely related to the device and not related to the procedure.It was reported as target lesion related and required percutaneous intervention.It was reported as not serious.The patient had a six month duplex ultrasound (dus) on the (b)(6) 2022 which showed severe stenosis of the target lesion (tl) stent.The patient was experiencing bilateral lower extremity edema.A diagnostic angiogram on the (b)(6) 2022 showed severe stenosis (99%) in the mid sfa just proximal to the target lesion stent and moderate in-stent restenosis (isr) within the proximal end of the stent as well.The patient had a percutaneous intervention on (b)(6) 2023, that involved drug coated balloon / drug eluting balloon (dcb/deb) and laser/atherectomy on the sfa middle to distal third segment.There was less than 20% residual stenosis.It was reported as a target vessel revascularisation (tvr).The patient outcome was reported as resolved/recovered and the device remains implanted.
Additional Manufacturer Narrative
This event is related to mdr report number 3011632150-2023-00056.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 event is related to mdr report number 3011632150-2023-00056.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 one biomimics 3d (bm3d) stent, a 6.0 x 150mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) middle third to distal third in the right leg.A retrograde 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.The site reported that on (b)(6) 2022, a restenosis of treated segment (target lesion) was identified.It was reported as definitely related to the device and not related to the procedure.It was reported as target lesion related and required percutaneous intervention.It was reported as not serious.The patient had a six month duplex ultrasound (dus) on the (b)(6) 2022 which showed severe stenosis of the target lesion (tl) stent.The patient was experiencing bilateral lower extremity edema.A diagnostic angiogram on the (b)(6) 2022 showed severe stenosis (99%) in the mid sfa just proximal to the target lesion stent and moderate in-stent restenosis (isr) within the proximal end of the stent as well.The patient had a percutaneous intervention on (b)(6) 2023, that involved drug coated balloon / drug eluting balloon (dcb/deb) and laser/atherectomy on the sfa middle to distal third segment.There was less than 20% residual stenosis.It was reported as a target vessel/lesion revascularisation (tvr/tlr).The patient outcome was reported as resolved/recovered and the device remains implanted.
Additional Manufacturer Narrative
This event is related to mdr report number 3011632150-2023-00056.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 event is related to mdr report number (b)(4).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 one biomimics 3d (bm3d) stent, a 6.0 x 150mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) middle third to distal third in the right leg.A retrograde 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.The site reported that on (b)(6) 2022, a restenosis of treated segment (target lesion) was identified.It was reported as definitely related to the device and not related to the procedure.It was reported as target lesion related and required percutaneous intervention.The patient had a six month duplex ultrasound (dus) on the (b)(6) 2022 which showed severe stenosis of the target lesion (tl) stent.The patient was experiencing bilateral lower extremity edema.A diagnostic angiogram on the (b)(6) 2022 showed severe stenosis (99%) in the mid sfa just proximal to the target lesion stent and moderate in-stent restenosis (isr) within the proximal end of the stent as well.The patient had a percutaneous intervention on (b)(6) 2023, that involved drug coated balloon / drug eluting balloon (dcb/deb) and laser/atherectomy on the sfa middle to distal third segment.There was less than 20% residual stenosis.It was reported as a target vessel/lesion revascularisation (tvr/tlr).The patient outcome was reported as resolved/recovered and the device remains implanted.
Additional Manufacturer Narrative
This event is related to mdr report number (b)(4).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.

• 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: 16907348
• Report Number: 3011632150-2023-00057
• Device Sequence Number: 15162755
• Product Code: NIP
• UDI-Device Identifier: 05391526850510
• UDI-Public: (01)05391526850510(17)230203(11)210705(10)0000096645
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P180003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 11/24/2023

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: 02/03/2023
• Device Model Number: 144700-12
• Device Catalogue Number: 144700-12
• Device Lot Number: 0000096645
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 09/25/2023; 11/01/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 10/24/2023; 11/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN.; CLOPIDOGREL (PLAVIX).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White