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

Catalog Number	144700-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	12/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This patient was enrolled in the mimics 3d usa post-market observational registry study.On (b)(6) 2022, the patient was implanted with one 6.0 x 150 mm biomimics 3d (bm3d) stent.It was used to treat a denovo lesion in the superficial femoral artery (sfa) distal third to proximal popliteal in the left leg.A contralateral approach was used and the treated segment was pre-dilated with percutaneous transluminal angioplasty (pta) and athectomy was used.The treated segment was post-dilated with pta.On the 05-dec-23, the site identified a restenosis of treated segment (target lesion).It was reported as not related to the device or the procedure but was due to a worsening pre-existing condition.It required percutaneous intervention.It was reported as target lesion related.The patient had 80% stenosis in the mid to distal sfa and proximal edge of stent in proximal sfa.The event was treated on 05-dec-23 and involved pta/standard balloon angioplasty and laser/atherectomy.This intervention was a target lesion/vessel revascularisation (tlr/tvr).The anterior tibial (at) proximal third to distal third was also treated with laser/atherectomy.The outcome was reported as resolved/recovered.The device remains implanted.Veryan's date of awareness of this event was the 12-aug-24.
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 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 patient was enrolled in the mimics 3d usa post-market observational registry study.On (b)(6) 2022, the patient was implanted with one 6.0 x 150 mm biomimics 3d (bm3d) stent.It was used to treat a denovo lesion in the superficial femoral artery (sfa) distal third to proximal popliteal in the left leg.A contralateral approach was used and the lesion was prepared and pre-dilated with percutaneous transluminal angioplasty (pta) and atherectomy.The treated segment was post-dilated with pta.On (b)(6) 2023, the site identified a restenosis of treated segment (target lesion).It was reported as not related to the device or the procedure but was due to a worsening pre-existing condition.It required percutaneous intervention.It was reported as target lesion related.The patient had 80% stenosis in the mid to distal sfa and proximal edge of stent in the sfa distal and proximal popliteal segment.The event was treated on (b)(6) 2023 and involved pta/standard balloon angioplasty and laser/atherectomy of the sfa proximal third to sfa distal third.This intervention was a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.The device remains implanted.Additional information received from the site on 17-oct-2024, reported that the stenosis involved the proximal popliteal segment.
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-conformance's 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 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.Section b.5.Was updated with additional information received from the site, sections g.6.And h.2.Were updated to reflect the report type (follow-up 01) and the reason and section h.11.Was updated to reflect the sections of this report that have changed.

• 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: 20124127
• Report Number: 3011632150-2024-00045
• Device Sequence Number: 3187700
• Product Code: NIP
• UDI-Device Identifier: 05391526850510
• UDI-Public: (01)05391526850510(17)230825(11)220124(10)0000130802
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/15/2024

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: 08/25/2023
• Device Catalogue Number: 144700-12
• Device Lot Number: 0000130802
• 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: 08/12/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2022
• 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.; BRILLINTA.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 132 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White