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

Model Number	142122-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Discomfort (2330); Restenosis (4576)
Date of Event	01/23/2023
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 effects of restenosis leading to intervention and leg pain/claudication are listed in the biomimics 3d instructions for use and are 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) 2022, the patient was implanted with one biomimics 3d (bm3d) stent (a 7.0 x 125mm stent) to treat a denovo lesion of the superficial femoral artery (sfa) proximal third in the right leg.A contralateral approach was used and the lesion was pre-dilated with percutaneous transluminal angioplasty (pta) and atherectomy.The treated segment was post-dilated with pta.The site reported that on (b)(6) 2023, a restenosis of treated segment (target lesion) was identified.The patient was seen in the clinical office on (b)(6) 2023 with some right leg discomfort.Duplex ultrasound (dus) showed high-grade velocities in proximal and mid sfa with significant dropping flows distal to this and decreasing ankle brachial indexes (abis).A right leg angiogram was conducted on (b)(6) 2023.The event was successfully treated with medication and percutaneous intervention, which involved a pta / standard balloon angioplasty of the sfa proximal third and anterior tibial artery on(b)(6) 2023 with good results.It was reported as a target lesion revascularisation (tlr) / target vessel revascularisation (tvr).The event of restenosis was reported as possibly related to the device and not related to the procedure.It was reported as target lesion related.The patient outcome was reported as resolved/recovered and the device remains implanted.
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 effects of restenosis leading to intervention and leg pain/claudication 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.Sections b.3.And b.5.Were updated to reflect the date of onset and updated distal segment details, sections d.3.And g.1.Were updated to reflect veryan's address, sections g.6.And h.2.Were updated to reflect the type of report (follow-up 01) and the reason.Section h.11.Was updated to reflect the sections changed in this report.
Event or Problem Description
The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6)2022, the patient was implanted with one biomimics 3d (bm3d) stent (a 7.0 x 125 mm stent) to treat a denovo lesion of the superficial femoral artery (sfa) proximal third in the right leg.A contralateral approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was post-dilated with pta.The site reported that on (b)(6)2023, a restenosis of treated segment (target lesion) was identified.The patient was seen in the clinical office on (b)(6)2023 with some right leg discomfort.Duplex ultrasound (dus) showed high-grade velocities in proximal and mid sfa with significant dropping flows distal to this and decreasing ankle brachial indexes (abis).A right leg angiogram was conducted on (b)(6)2023.The event was successfully treated with medication and percutaneous intervention, which involved a pta / standard balloon angioplasty of the sfa proximal third and anterior tibial (at) distal third artery on (b)(6)2023 with good results.It was reported as a target lesion/vessel revascularisation (tlr/tvr).The event of restenosis was reported as possibly related to the device and not related to the procedure.It was reported as target lesion related.The patient outcome was reported as resolved/recovered and the device remains implanted.Additional information received on 14-nov-24 by veryan updated the date of onset of the event to 23-jan-23 and also updated the distal segment treated during the intervention to the at distal third.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Common Device Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL; 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: 16479206
• Report Number: 3011632150-2023-00028
• Device Sequence Number: 14240516
• Product Code: NIP
• UDI-Device Identifier: 05391526850497
• UDI-Public: (01)05391526850497(17)221007(11)210308(10)0000076765
• 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: 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
• Report Date (Section B): 12/11/2024

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: 10/07/2022
• Device Model Number: 142122-15
• Device Catalogue Number: 142122-15
• Device Lot Number: 0000076765
• 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: 02/03/2023
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 91 KG