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

Catalog Number	142122-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	06/26/2023
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 effect of restenosis leading to intervention is listed in the biomimics 3d instructions for use and is a known patient effects 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) 22, the patient was implanted with one biomimics 3d (bm3d) stent in the right leg, a 7.0 x 60 mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) proximal third.A retrograde approach was used and the lesion was prepared using pre-dilation with a percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was post-dilated with pta.The site identified a restenosis of treated vessel (target vessel) event on (b)(6) 22.It was reported as not related to the device and not related to the procedure but due to a worsening pre-existing condition.Diagnostic angiography was performed on the right lower extremity (rle) but no intervention was performed initially, secondary to an unscheduled follow-up and ultrasound on (b)(6) 22, a focal right distal sfa occlusion without any other evidence of flow-limiting disease, and monophasic heavily calcified dorsal metatarsal were identified.The intervention was performed on (b)(6) 23 and was reported as a target lesion/vessel revascularisation (tlr/tvr) that involved pta / standard balloon angioplasty and laser/atherectomy on the sfa proximal third to sfa middle third.The outcome was reported as continuing.The device remains implanted.The event was reviewed by veryan on 18-dec-23 and considered possibly related to the device.
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 in the right leg, a 7.0 x 60 mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) proximal third.A retrograde approach was used and the lesion was prepared using pre-dilation with a percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was post-dilated with pta.The site identified a restenosis of treated segment (target lesion) event on 26-jun-23.It was reported as not related to the device and not related to the procedure but due to a worsening pre-existing condition.It was target lesion-related and required a percutaneous intervention.Diagnostic angiography was performed on the right lower extremity (rle) but no intervention was performed initially, secondary to an unscheduled follow-up and ultrasound on (b)(6) 2022, a focal right distal sfa occlusion without any other evidence of flow-limiting disease, and monophasic heavily calcified dorsal metatarsal were identified.The intervention was performed on (b)(6) 2023 and was reported as a target vessel revascularisation (tvr) and target lesion revascularisation (tlr) that involved pta / standard balloon angioplasty and laser/atherectomy on the sfa proximal third to the plantar arch.The outcome was reported as resolved/recovered.The device remains implanted.The event was reviewed by veryan on 18-dec-23 and considered possibly related to the device.Additional information was received from the site and reviewed by veryan on 02-apr-24 where the previously reported event of restenosis of treated vessel (target vessel) event was updated as not related to a tlr intervention.The details of this event and updates received by the site were reviewed again on 29-apr-24, and this event was updated to a restenosis of treated segment (target lesion) and the updated details of the intervention were captured which included an update to the tlr field and the segment treated at the intervention which was the sfa proximal third to the plantar arch.
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.Sections a.1.And a.2.Were updated to reflect a change to the patient identifier and age of the patient at the time of the event.Section b.3.Was updated to reflect the event date of onset.Section b.5.Was updated with the additional information received.Sections g.6.And h.2.Were updated to reflect the type of the report (follow-up 01) and the reason and section h.11.Was updated to reflect the sections of this report that have been changed.

• 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: 18516305
• Report Number: 3011632150-2023-00150
• Device Sequence Number: 20520771
• Product Code: NIP
• UDI-Device Identifier: 05391526850404
• UDI-Public: (01)05391526850404(17)230416(11)210915(10)0000108760
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2024

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: 04/16/2023
• Device Catalogue Number: 142122-03
• Device Lot Number: 0000108760
• 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: 12/18/2023
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2021
• 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: ATORVASTATIN; CLOPIDOGREL (PLAVIX); XARELTO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 222 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White