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

Model Number	142122-07
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	04/04/2022
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 80mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) middle third to distal third in the left 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 not serious.A duplex ultrasound (dus) on (b)(6)2022 at the patient's 12-month follow-up showed elevated velocities in the left sfa.A diagnostic angiogram performed on (b)(6)2022 showed a 50-60% stenosis at the proximal end of the target lesion stent.It was decided to manage the event medically by adding cilostazol.No further diagnostics or interventions were reported.The patient outcome was reported as continuing and the device remains implanted.
Event or Problem Description
The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6) 2021 the patient was implanted with one biomimics 3d (bm3d) stent, a 7.0 x 80mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) middle third to distal third in the left 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 not serious.A duplex ultrasound (dus) on (b)(6) 2022 at the patient's 12-month follow-up showed elevated velocities in the left sfa.A diagnostic angiogram performed on (b)(6) 2022 showed a 50-60% stenosis at the proximal end of the target lesion stent.It was decided to manage the event medically by adding cilostazol.No further diagnostics or interventions were reported.The patient outcome was reported as continuing and the device remains implanted.Additional information received on 12-mar-24 stated that there were no changes since the event was reported.
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.Section b.5.Was updated with the additional information received, sections d.3.And g.1.Were updated with veryan's address details which have changed since the submission of the initial report, sections g.6.And h.2.Were updated to reflect the type of report (follow-up 01) and reason, section h.6.Was updated to include medication required and h.11.Identifies the sections of the report that have been updated.
Event or Problem Description
The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6) 2021, the patient was implanted with one biomimics 3d (bm3d) stent, a 7.0 x 80 mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) middle third to distal third in the left 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 not serious.A duplex ultrasound (dus) on (b)(6) 2022 at the patient's 12-month follow-up showed elevated velocities in the left sfa.A diagnostic angiogram performed on (b)(6) 2022 showed a 50-60% stenosis at the proximal end of the target lesion stent.It was decided to manage the event medically by adding cilostazol.No further diagnostics or interventions were reported.The patient outcome was reported as continuing and the device remains implanted.Additional information received on 23-apr-24 stated that as of the patient's study exit on (b)(6) 2024, the event was ongoing and no interventions were planned.
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.Section b.5.Was updated with the additional information received, sections g.6.And h.2.Were updated to reflect the type of report (follow-up 02) and reason, and section h.11.Identifies the sections of the report that have been changed.

• 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: 16916659
• Report Number: 3011632150-2023-00065
• Device Sequence Number: 7033299
• Product Code: NIP
• UDI-Device Identifier: 05391526850435
• UDI-Public: (01)05391526850435(17)220617(11)201116(10)0000058438
• 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: 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): 05/21/2024

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: 06/17/2022
• Device Model Number: 142122-07
• Device Catalogue Number: 142122-07
• Device Lot Number: 0000058438
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 03/12/2024; 04/23/2024
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 04/09/2024; 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 331 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White