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

Catalog Number	144700-19
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Restenosis (4576)
Date of Event	12/05/2022
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 effects of restenosis leading to interventions 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) 2021, the patient was implanted with one 7.0 x 150 mm biomimics 3d (bm3d) stent in the right leg to treat a denovo lesion of the superficial femoral artery (sfa) middle third to distal third.A contralateral approach was used and the lesion was prepared with atherectomy.The treated segment was post-dilated with percutaneous transluminal angioplasty (pta) balloon.The site identified a restenosis of treated segment (target lesion) on (b)(6) 2022.It was reported as not related to the study device and not related to the study procedure.It was due to a worsening pre-existing condition.It was target lesion related.The patient presented at the clinic for a follow-up visit on (b)(6) 2022 with worsening claudication symptoms and rutherford class (rc) 3 symptoms.The intervention was performed on (b)(6) 2022 and involved pta/standard balloon angioplasty and laser atherectomy of the sfa proximal third to middle third.The intervention was reported as a target lesion/vessel revascularisation (tlr/tvr).A bilateral leg extremity (ble) diagnostic angiogram was completed on (b)(6) 2022 and identified moderate in-stent stenosis of distal sfa (target lesion) and an intervention was scheduled.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 effects of restenosis leading to interventions 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.
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 7.0 x 150 mm biomimics 3d (bm3d) stent in the right leg to treat a denovo lesion of the superficial femoral artery (sfa) middle third to distal third.A contralateral approach was used and the lesion was prepared with atherectomy.The treated segment was post-dilated with percutaneous transluminal angioplasty (pta) balloon.The site identified a restenosis of treated segment (target lesion) on (b)(6) 2022.It was reported as not related to the study device and not related to the study procedure.It was due to a worsening pre-existing condition.It was target lesion related.The patient presented at the clinic for a follow-up visit on (b)(6) 2022 with worsening claudication symptoms and rutherford class (rc) 3 symptoms.A bilateral leg extremity (ble) diagnostic angiogram was completed on (b)(6) 2022 and identified moderate in-stent stenosis of distal sfa (target lesion) and an intervention was scheduled.A stent placement was performed on (b)(6) 2023 on the left proximal sfa (non-study leg).An intervention was performed on (b)(6) 2023 and involved non bm3d bare metal stent placement, pta/standard balloon angioplasty and laser atherectomy of the right sfa middle third to anterior tibial (at) proximal third.The stent placement was in the right sfa and pta was performed on the at artery.The intervention was reported as a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.The device remains implanted.

• 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: 17865148
• Report Number: 3011632150-2023-00123
• Device Sequence Number: 5692539
• Product Code: NIP
• UDI-Device Identifier: 05391526850527
• UDI-Public: (01)05391526850527(17)220417(11)200916(10)0000052116
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 11/10/2023

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: 04/17/2022
• Device Catalogue Number: 144700-19
• Device Lot Number: 0000052116
• 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: 09/08/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2020
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American