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

Catalog Number	142122-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Restenosis (4576)
Date of Event	06/28/2023
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 treated as part of the mimics 3d usa post-market observational study.On the (b)(6) 2021, the patient was implanted with one biomimics 3d (bm3d) stent in the left leg, a 7.0 x 60 mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) middle third to distal third segment.An antegrade approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was post dilated with pta.The site identified a restenosis of treated vessel (target vessel) on (b)(6) 2023.It was reported as not related to the device or procedure but was due to a worsening pre-existing condition.It was also reported as target lesion related.The patient had left leg extremity (lle) pain.Duplex ultrasound (dus) on (b)(6) 2023 showed restenosis of the proximal stent.A left leg angiogram on (b)(6) 2023 was performed for an in-stent restenosis (isr).This included laser and plain old balloon angioplasty (poba).The outcome was reported as continuing.The device remains implanted.The event was reviewed on 06-jul-23 by veryan and considered possibly related to the device.
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 biomimics 3d (bm3d) stent in the left leg, a 7.0 x 60 mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) middle third to distal third segment.An antegrade approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was post-dilated with pta.The site identified a restenosis of treated segment (target lesion) on (b)(6) 2023.It was reported as not related to the device or procedure but was due to a worsening pre-existing condition.It was also reported as target lesion related.The patient had left lower extremity (lle) pain.Duplex ultrasound (dus) on (b)(6) 2023 showed restenosis of the proximal stent.A left leg angiogram on (b)(6) 2023 was performed for an in-stent restenosis (isr).This included laser/atherectomy and plain old balloon angioplasty (poba)/pta/standard balloon angioplasty on the sfa distal third.It was a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.The device remains implanted.The event was reviewed originally on (b)(6) 2023 by veryan and considered possibly related to the device.There was updated information received on (b)(6) 2023 in relation to the event, the outcome and the intervention details.
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.Sections b.5.And g.6.And h.10.Have been updated.

• 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: 17446657
• Report Number: 3011632150-2023-00097
• Device Sequence Number: 7288356
• Product Code: NIP
• UDI-Device Identifier: 05391526850404
• UDI-Public: (01)05391526850404(17)220523(11)201022(10)0000056142
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/11/2024

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: 05/23/2022
• Device Catalogue Number: 142122-03
• Device Lot Number: 0000056142
• 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: Not provided
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2020
• 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: CLOPIDOGREL (PLAVIX); ELIQUIS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American