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

Model Number	142122-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is related to mdr number 3011632150-2022-00032.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 arterial thrombosis 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 mdr is related to 3011632150-2022-00032.The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2021.The subject was implanted with two biomimics-3d stents (a 7.0 x 60mm and a 7.0 x 80mm) to treat a denovo lesion of the sfa middle third to sfa distal third of the left leg.A contralateral approach was used and pre-dilatation and post-dilatation of the target lesion was conducted with percutaneous transluminal angioplasty.Atherectomy was also performed pre-stent placement.On an unknown date in june 2021, an event of thrombosis of treated segment was identified and reported to veryan on (b)(6) 2022.It was reported as "not related" to the device or procedure but to a worsening of the pre-existing condition.The event required a target lesion revascularisation (tlr) that involved percutaneous transluminal angioplasty / standard balloon angioplasty and thrombectomy.The event is reported as serious.The patient outcome is described as resolved/recovered.The devices remain implanted.On review of the event by veryan, it was determined to be possibly related to the device due to the target lesion relationship.
Event or Problem Description
This mdr is related to 3011632150-2022-00032.The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2021.The subject was implanted with two biomimics-3d stents (a 7.0 x 60mm and a 7.0 x 80mm) to treat a denovo lesion of the superficial femoral artery (sfa) middle third to sfa distal third of the left leg.A contralateral approach was used and pre-dilatation and post-dilatation of the target lesion was conducted with percutaneous transluminal angioplasty (pta).Atherectomy was also performed pre-stent placement.On an unknown date in (b)(6) 2021, an event of thrombosis was identified and reported to veryan on (b)(6) 2022.It was reported as "not related" to the device or procedure but to a worsening of the pre-existing condition.On (b)(6) 2021, the patient underwent pta/standard balloon angioplasty and thrombectomy on the distal popliteal to peroneal ostial segment.The patient outcome is reported as resolved/recovered.The devices remain implanted.Additional information received reported that the event was not related to the target lesion and the event did not result in target lesion revascularisation or target vessel revascularisation.This event does not meet mdr reportable criteria based on the updated information and this supplemental report is being provided to update the initial report.
Additional Manufacturer Narrative
This is related to mdr number 3011632150-2022-00032.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 arterial thrombosis 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.Has been updated to highlight that this event was not related to the device or target lesion and based on the updated information this event would not meet mdr reportable event criteria.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Common Device Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL LTD; unit 11 galway technology park; parkmore road; galway city, H91 V E0H; EI H91 VE0H
• Manufacturer Contact: alan mcdonagh ; unit 11 galway technology park; parkmore road; galway city, H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 14563025
• Report Number: 3011632150-2022-00031
• Device Sequence Number: 17438956
• Product Code: NIP
• UDI-Device Identifier: 05391526850404
• UDI-Public: (01)05391526850404(17)220417(11)200916(10)0000052114
• 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): 12/13/2022

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: 04/17/2022
• Device Model Number: 142122-03
• Device Catalogue Number: 142122-03
• Device Lot Number: 0000052114
• 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: 05/05/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2020
• 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.; ELIQUIS.; WARFARIN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American