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

Model Number	142122-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	12/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is related to mdr report number 3011632150-2023-00054.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
This is related to mdr number 3011632150-2023-00054.The patient was enrolled in the mimics 3d usa post-market observational study on the (b)(6) 2021.They were treated with two 6.0 x 100mm biomimics 3d (bm3d) stents to treat a denovo lesion of the superficial femoral artery (sfa) distal third to proximal popliteal segment in the right leg.A contralateral approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) and atherectomy.The treated segment was also post-dilated with pta.On the (b)(6) 2022, the site identified a restenosis of treated segment (target lesion).The event was reported as not serious but required percutaneous intervention.The patient presented to the clinic for a 12-month visit with abnormal arterial ultrasound.A bilateral leg extremity (ble) diagnostic angiogram conducted on (b)(6) 2023 showed target lesion re-stenosis.There was a re-intervention on the target limb and lesion completed on (b)(6) 2023.It involved non bm3d bare metal stent placement of the right mid sfa extending into the proximal portion of the stent, drug coated balloon/drug eluting balloon (dcb/deb) and pta/standard balloon angioplasty of the sfa ostial to distal popliteal segment.It was reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).The event was reported as possibly related to the device but not related to the procedure.It was target lesion related.The outcome was reported as resolved with sequelae.The devices remain implanted.
Event or Problem Description
This is related to mdr number 3011632150-2023-00054.The patient was enrolled in the mimics 3d usa post-market observational study on the (b)(6) 2021.They were treated with two 6.0 x 100mm biomimics 3d (bm3d) stents to treat a denovo lesion of the superficial femoral artery (sfa) distal third to proximal popliteal segment in the right leg.A contralateral approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) and atherectomy.The treated segment was also post-dilated with pta.On the (b)(6) 2022, the site identified a restenosis of treated segment (target lesion).The event required percutaneous intervention.The patient presented to the clinic for a 12-month visit with abnormal arterial ultrasound.A bilateral leg extremity (ble) diagnostic angiogram conducted on (b)(6) 2023 showed target lesion re-stenosis.There was a re-intervention on the target limb and lesion completed on (b)(6) 2023.It involved non bm3d bare metal stent placement of the right mid sfa extending into the proximal portion of the stent, drug coated balloon/drug eluting balloon (dcb/deb) and pta/standard balloon angioplasty of the sfa ostial to distal popliteal segment.It was reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).The event was reported as possibly related to the device but not related to the procedure.It was target lesion related.The outcome was reported as resolved with sequelae.The devices remain implanted.
Additional Manufacturer Narrative
This is related to mdr number 3011632150-2023-00054.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: 16833415
• Report Number: 3011632150-2023-00055
• Device Sequence Number: 13930007
• Product Code: NIP
• UDI-Device Identifier: 05391526850459
• UDI-Public: (01)05391526850459(17)220401(11)200831(10)0000050211
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 10/03/2023

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: 04/01/2022
• Device Model Number: 142122-10
• Device Catalogue Number: 142122-10
• Device Lot Number: 0000050211
• 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: 04/01/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White