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

Catalog Number	142122-07
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	03/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to mdr 3011632150-2024-00047.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 occlusion 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
This report is related to mdr number 3011632150-2024-00047.This patient was enrolled in the mimics 3d usa post-market observational registry study.On (b)(6) 2021, the patient was implanted with two biomimics 3d (bm3d) stents.A 7.0 x 80 mm stent (the subject of this report) and a 7.0 x 150 mm stent was used treat a denovo lesion in the superficial femoral artery (sfa) proximal third to sfa middle third in the left leg.A contralateral approach was used and the lesion was pre-dilated with percutaneous transluminal angioplasty (pta), and an inpact drug coated/eluting balloon (dcb/deb) and cutting balloon were used.The treated segment was post-dilated with pta.On (b)(6) 2022, the site identified an occlusion.It was reported as possibly related to the device but not related to the procedure.It required percutaneous intervention.It was reported as target lesion related.The patient had a computed tomography (ct) scan that demonstrated the left sfa was 100% occluded.The patient then had percutaneous intervention of the left sfa proximal/middle portion, that was previously treated with the bm3d stent.The distal sfa was also treated.This sfa was successfully treated with rotarex laser/atherectomy and a lutonix dcb/deb.The distal sfa was treated with a non-bm3d drug eluting stent (des) stent.The intervention was performed on (b)(6) 2022 on the sfa proximal third to anterior tibial (at) proximal third.It was a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.The devices remain implanted.Veryan's date of awareness of this event was the 30-aug-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 ; EI H91 V0TX
• MDR Report Key: 20246038
• Report Number: 3011632150-2024-00046
• Device Sequence Number: 17962458
• Product Code: NIP
• UDI-Device Identifier: 05391526850435
• UDI-Public: (01)05391526850435(17)220906(11)210205(10)0000070517
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2024

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: 09/06/2022
• Device Catalogue Number: 142122-07
• Device Lot Number: 0000070517
• 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: 08/30/2024
• Initial Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White