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

Model Number	142122-09
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Restenosis (4576)
Date of Event	05/11/2023
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 and leg pain/claudication are listed in the biomimics 3d instructions for use and are 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 the (b)(6) 2022, the patient was implanted with one biomimics 3d (bm3d) stent, a 5.0 x 100 mm stent was used to treat a denovo lesion of the superficial femoral artery (sfa) proximal third in the left leg.A contralateral approach was used and the lesion was prepared using atherectomy.The treated segment was post-dilated with percutaneous transluminal angioplasty (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 due to a worsening pre-existing condition.It was also reported as target lesion related.The patient was in for follow-up and ultrasound on (b)(6) 2023, at this follow-up he reported returned claudication symptoms related to the target limb (left).The ultrasound showed greater than 75% in-stent stenosis of the left proximal sfa.An angiogram with laser atherectomy and drug coated/drug eluting balloon (dcb/deb) angioplasty was performed on (b)(6) 2023 with a positive result.During this angiogram, intravascular ultrasound (ivus) revealed 73.8% stenosis in the proximal sfa stent.After performing laser atherectomy and treating with a 6mm dcb/deb, ivus revealed wide patency of the treated segment.The patient was discharged home on the same day.The intervention was reported as a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.The device remains implanted.This event was reviewed by veryan and considered possibly related to the device.
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 and leg pain/claudication are listed in the biomimics 3d instructions for use and are 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, sections d.3.And g.1.Were updated to reflect veryan's new address details, section d.10.Was updated to reflect a change in the start date of the eliquis therapy, sections g.6.And h.2.Were updated to reflect the type of report (follow-up 01) and the reasons.Section h.11.Was updated to reflect the sections changed in this report.
Event or Problem Description
The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6) 2022, the patient was implanted with one biomimics 3d (bm3d) stent, a 5.0 x 100 mm stent was used to treat a denovo lesion of the superficial femoral artery (sfa) proximal third in the left leg.A contralateral approach was used and the lesion was prepared using atherectomy.The treated segment was post-dilated with percutaneous transluminal angioplasty (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 due to a worsening pre-existing condition.It was also reported as target lesion-related.The patient was in for a follow-up and ultrasound on (b)(6) 2023, at this follow-up he reported returned claudication symptoms related to the target limb (left).The ultrasound showed greater than 75% in-stent stenosis of the left proximal sfa.An angiogram with laser atherectomy and drug coated/drug eluting balloon (dcb/deb) angioplasty was performed on (b)(6) 2023 with a positive result.During this angiogram, intravascular ultrasound (ivus) revealed 73.8% stenosis in the proximal sfa stent.After performing laser atherectomy and treating with a 6mm dcb/deb, ivus revealed wide patency of the treated segment.The patient was discharged home on the same day.The intervention was reported as a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.The device remains implanted.This event was reviewed by veryan and considered possibly related to the device.Additional information was reviewed by veryan on 15-apr-24 which included the clinical events committee (cec) adjudication of this event.It was determined that it was not related to the study device due to the previous manipulations of the vessel that were part of the previous tlr to treat the first event.This was the second restenosis of the segment where the study stent was placed.The first restenosis of the study stented segment was reported as mdr 3011632150-2022-00126.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Common Device Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL; 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: 17258045
• Report Number: 3011632150-2023-00084
• Device Sequence Number: 14967078
• Product Code: NIP
• UDI-Device Identifier: 05391526850442
• UDI-Public: (01)05391526850442(17)220906(11)210205(10)0000070518
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 05/13/2024

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 Model Number: 142122-09
• Device Catalogue Number: 142122-09
• Device Lot Number: 0000070518
• 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: 06/06/2023
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN; ASPIRIN; ELIQUIS; ELIQUIS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 230 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White