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

Catalog Number	142122-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Restenosis (4576)
Date of Event	08/11/2023
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 claudication/leg pain 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 enrolled in the mimics 3d usa post-market observational study.On (b)(6) 2022, the patient was implanted with one biomimics 3d (bm3d) 5.0 x 60 mm stent to treat a denovo lesion in the left superficial femoral artery (sfa) distal third.A retrograde approach was used and the lesion was stented and post-dilated with a percutaneous transluminal angioplasty (pta) balloon.On (b)(6) 2023, a restenosis of the treated segment (target lesion) was identified and it was reported as possibly related to the device and not related to the procedure.It was target lesion-related.It was identified at the patient's 12-month follow-up visit.The patient was experiencing rutherford class (rc) 3 symptoms in the left leg.Duplex ultrasound (dus) showed stenosis in the left distal sfa (target lesion).A diagnostic angio on (b)(6) 2023 showed severe in-stent restenosis at (b)(4).An intervention was performed on (b)(6) 2023.A laser atherectomy was performed within the existing stent, followed by drug coated/eluting balloon (dcb/deb).Residual stenosis was less than (b)(4) afterwards.The intervention was a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved recovered.

• 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: 19069142
• Report Number: 3011632150-2024-00017
• Device Sequence Number: 12487858
• Product Code: NIP
• UDI-Device Identifier: 05391526850381
• UDI-Public: (01)05391526850381(17)230929(11)220228(10)0000136621
• 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): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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
• Device Expiration Date: 09/29/2023
• Device Catalogue Number: 142122-01
• Device Lot Number: 0000136621
• 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: 03/11/2024
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2022
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American