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

Model Number	142122-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	04/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2021.The subject was implanted with one biomimics 3d (bm3d) stent ( 5.0 x 60mm stent) to treat a denovo lesion of the sfa middle third in the right leg.A contralateral approach was used and pre-dilatation was conducted with percutaneous transluminal angioplasty (pta), and atherectomy were used to prepare the lesion while post-dilation was also conducted using pta.On the (b)(6) 2022, an event of restenosis of treated segment (target lesion) was reported from the site.It was reported as "not related" to the device and "not related" to the procedure.It was also reported as target lesion related.The patient outcome is reported as "resolved/recovered".It led to a percutaneous intervention and it involved a target lesion revascularisation on (b)(6) 2022 with pta balloon angioplasty and laser atherectomy.The device remains implanted.This was reviewed by veryan on (b)(6) 2022 and considered possibly related to the device.The site subsequently updated the device relationship to "possibly related" on (b)(6) 2022.
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.
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
The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2021.The subject was implanted with one biomimics 3d (bm3d) stent (a 5.0 x 60mm stent) to treat a denovo lesion of the sfa middle third in the right leg.A contralateral approach was used.The lesion was prepared using percutaneous transluminal angioplasty (pta) and atherectomy while post-dilation of the treated segment was also conducted using pta.On the (b)(6) 2022, an event of restenosis of treated vessel (target vessel) was identified by the site on ultrasound which identified an in-stent stenosis.It was reported as "possibly related" to the device and "not related" to the procedure.It was reported as not being target lesion related.It led to a percutaneous intervention on the sfa distal third on (b)(6) 2022 with pta/standard balloon angioplasty and laser atherectomy.It was not a target lesion revascularisation (tlr) but was a target vessel revascularisation (tvr).The device remains implanted.The patient outcome is reported as "resolved/recovered".
Event or Problem Description
The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2021.The patient was implanted with one biomimics 3d (bm3d) stent (a 5.0 x 60mm stent) to treat a denovo lesion of the sfa middle third in the right leg.A contralateral approach was used.The lesion was prepared using percutaneous transluminal angioplasty (pta) and atherectomy while post-dilation of the treated segment was also conducted using pta.On the 06-apr-22, an event of restenosis of treated segment (target lesion) was identified by the site on ultrasound which identified an in-stent stenosis.It was reported as "possibly related" to the device and "not related" to the procedure.It was reported as target lesion related.It led to a percutaneous intervention on the sfa middle third on (b)(6) 2022 with pta/standard balloon angioplasty and laser atherectomy.It was reported as a target lesion/vessel revascularisation (tlr/tvr).The device remains implanted.The patient outcome was reported as "resolved/recovered".The updates received by the site on 30-nov-23 updated this event from a restenosis of treated vessel (target vessel) to restenosis of treated segment (target lesion).The target lesion related field was updated from "no" to "yes" and the tlr field was updated from "no" to "yes".
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.

• 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: 15196909
• Report Number: 3011632150-2022-00071
• Device Sequence Number: 16700640
• Product Code: NIP
• UDI-Device Identifier: 05391526850381
• UDI-Public: (01)05391526850381(17)220523(11)201022(10)0000055758
• 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,Followup
• Report Date (Section B): 12/19/2023

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: 05/23/2022
• Device Model Number: 142122-01
• Device Catalogue Number: 142122-01
• Device Lot Number: 0000055758
• 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: 07/11/2022
• Supplement Date Received by Manufacturer: 06/21/2023; 11/30/2023
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 07/21/2023; 12/19/2023
• 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: ASPIRIN; ASPIRIN; CLOPIDOGREL (PLAVIX); CLOPIDOGREL (PLAVIX); HEPARIN; HEPARIN
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White