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

Model 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	10/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to mdr number 3011632150-2023-00080.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 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 3011632150-2023-00080.The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6) 2021, the patient was implanted with two biomimics 3d (bm3d) stents, a 5.0 x 150 mm stent and a 6.0 x 150 mm (the subject of this report) stent which were used to treat a restenotic lesion of the superficial femoral artery (sfa) middle third to proximal popliteal artery in the left leg.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 and a drug coated / drug eluting balloon (dcb / deb).The site identified a restenosis of treated segment (target lesion) on (b)(6) 2022.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 had their left popliteal, left sfa and left posterior tibial (pt) artery revascularised using pta / standard balloon angioplasty, dcb / deb and shockwave treatment on the sfa proximal third to pt distal third on (b)(6) 2022.The intervention was reported as a target lesion / vessel revascularisation (tlr / tvr).The outcome was reported as resolved / recovered.The devices remain implanted.This event was reviewed by veryan and considered possibly related to the device.
Additional Manufacturer Narrative
This report is related to mdr number 3011632150-2023-00080.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 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, sections d.3.And g.1.Were updated with veryan's address details which have changed since submission of the initial report.Section g.6 and h.2.Have been updated to reflect the type of report (follow-up 01) and the reason.Section h.11.Was updated to reflect the sections of the report which have changed.
Event or Problem Description
This report is related to mdr number 3011632150-2023-00080.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 two biomimics 3d (bm3d) stents, a 5.0 x 150 mm stent and a 6.0 x 150 mm stent (the subject of this report) which were used to treat a restenotic lesion of the superficial femoral artery (sfa) middle third to proximal popliteal artery in the left leg.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 and a drug coated/ drug eluting balloon (dcb/deb).The site identified a restenosis of treated segment (target lesion) on (b)(6) 2022.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 had their left popliteal, left sfa and left posterior tibial (pt) arteries revascularised using pta / standard balloon angioplasty, dcb/deb and shockwave treatment on the sfa proximal third to pt distal third on (b)(6) 2022.The intervention was reported as a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.The devices remain implanted.This event was reviewed by veryan and considered possibly related to the device.Additional information was reviewed by veryan on 13-may-24 and this included the clinical events committee (cec) adjudication of the event which determined that this was not related to the devices implanted.This was the second restenosis of the treated segment that required a tlr intervention.As the segment had already been repeatedly manipulated as part of previous target lesion revascularisation (tlr) intervention, the relationship was most likely due to progression of the disease.The previous restenosis event was reported as mdr reports 3011632150-2022-00094 and 3011632150-2022-00095.

• 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: 17256270
• Report Number: 3011632150-2023-00081
• Device Sequence Number: 7966150
• Product Code: NIP
• UDI-Device Identifier: 05391526850510
• UDI-Public: (01)05391526850510(17)221125(11)210426(10)0000082299
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/11/2024

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: 11/25/2022
• Device Model Number: 144700-12
• Device Catalogue Number: 144700-12
• Device Lot Number: 0000082299
• 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: 05/13/2024
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• 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.; CLOPIDOGREL (PLAVIX).; XARELTO.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 132 KG
• Patient Ethnicity: Hispanic