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

Catalog Number	142122-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	06/08/2022
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 interventions 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 (b)(6) 2022, the patient was implanted with one 6.0 x 100 mm biomimics 3d (bm3d) stent in the left leg to treat a restenotic lesion of the superficial femoral artery (sfa) middle third.A retrograde approach was used and the lesion was prepared with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was post-dilated with a pta balloon.The site identified a restenosis of treated segment (target lesion) on (b)(6) 2022.It was reported as definitely related to the study device and not related to the study procedure.It was target lesion related.Duplex ultrasound (dus) performed on (b)(6) 2022 showed an occluded left distal sfa and popliteal artery.The subject was referred for an evaluation for a femoropopliteal bypass.On (b)(6) 2022, this was attempted but the procedure was aborted due to an inability to gain access to any lumen to evaluate the outflow in the vessels below the knee.On (b)(6) 2022, interventional cardiology performed a limb salvage procedure.Laser atherectomy and balloon angioplasty (drug coated/eluting balloon (dcb/deb) and pta/standard balloon angioplasty) were performed and two additional bm3d stents were placed in the denovo lesion in the sfa proximal third overlapping with the study stent that was implanted in the sfa middle third.Directional atherectomy of the popliteal and anterior tibial artery were also performed.The patient was started on xarelto and discharged on (b)(6) 2022.The intervention was reported as a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.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 effect of restenosis leading to interventions 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.The cec adjudicated this event as not related to the device.Section b.5.Was updated to reflect the cec adjudication, d.1.And d.2a were updated to correct "biomimics", g.6., and h.11.Have been updated to reflect the report type (follow-up 01) and the sections that have been updated in the report.
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 6.0 x 100 mm biomimics 3d (bm3d) stent in the left leg to treat a restenotic lesion of the superficial femoral artery (sfa) middle third.A retrograde approach was used and the lesion was prepared with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was post-dilated with a pta balloon.The site identified a restenosis of treated segment (target lesion) on (b)(6) 2022.It was reported as definitely related to the study device and not related to the study procedure.It was target lesion related.Duplex ultrasound (dus) performed on (b)(6) 2022 showed an occluded left distal sfa and popliteal artery.The subject was referred for an evaluation for a femoropopliteal bypass.On (b)(6) 2022, this was attempted but the procedure was aborted due to an inability to gain access to any lumen to evaluate the outflow in the vessels below the knee.On (b)(6) 2022, interventional cardiology performed a limb salvage procedure.Laser atherectomy and balloon angioplasty (drug coated/eluting balloon (dcb/deb) and pta/standard balloon angioplasty) were performed and two additional bm3d stents were placed in the denovo lesion in the sfa proximal third overlapping with the study stent that was implanted in the sfa middle third.Directional atherectomy of the popliteal and anterior tibial artery were also performed.The patient was started on xarelto and discharged on (b)(6) 2022.The intervention was reported as a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.The device remains implanted.The clinical events committee (cec) adjudicated that this event was not related to the device and this adjudication was reviewed by veryan on 06-feb-24.

• 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 ; RE H91 V0TX
• MDR Report Key: 18204607
• Report Number: 3011632150-2023-00137
• Device Sequence Number: 17746120
• Product Code: NIP
• UDI-Device Identifier: 05391526850459
• UDI-Public: (01)05391526850459(17)220715(11)201214(10)0000063198
• 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
• Report Date (Section B): 03/06/2024

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: 07/15/2022
• Device Catalogue Number: 142122-10
• Device Lot Number: 0000063198
• 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: 11/01/2023
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 11/24/2023
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2020
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 124 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White