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 Codes	Pain (1994); Restenosis (4576)
Date of Event	09/14/2022
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 and leg pian/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 7.0 x 60mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) proximal third in the right leg.A retrograde approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was also post dilated with pta.The site reported that on (b)(6) 2022, a restenosis of treated vessel (target vessel) was identified.The relationship to the device and procedure was reported as not assessable/unknown and due to a worsening pre-existing condition.It was reported as target lesion related and required percutaneous intervention.The patient presented with rest pain in the right foot.An arterial duplex ultrasound revealed recurrent right sfa occlusion and flow-limiting disease in the right posterior tibial artery.The patient had a known right anterior tibial artery occlusion.Due to the rest pain, the patient was scheduled for urgent right lower extremity angiography and intervention.The patient had drug coated balloon / drug eluting balloon, pta, laser atherectomy and placement of an additional bm3d 7.0 x 150mm stent in the sfa proximal third to middle third on (b)(6) 2022.The recanalisation was reported as successful.It was reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).The device remains implanted.
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.The reported patient effects of restenosis leading to intervention and leg pain/claudication are listed in the biomimics 3d instructions for use and are 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.Sections b.5., d.3., e.1., g.1., g.6.And h.10.Have been updated.
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 7.0 x 60 mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) proximal third in the right leg.A retrograde approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was also post-dilated with pta.The site reported that on (b)(6) 2022, a restenosis of treated segment (target lesion) was identified.The relationship to the device and procedure was reported as not assessable/unknown and due to a worsening pre-existing condition.It was reported as target lesion related and required percutaneous intervention.The patient presented with rest pain in the right foot and rutherford class iv disease.An arterial duplex ultrasound revealed recurrent right sfa occlusion and flow-limiting disease in the right posterior tibial artery.The patient had a known right anterior tibial artery occlusion.Due to the rest pain, the patient was scheduled for urgent right lower extremity angiography and intervention.The patient had drug coated balloon / drug eluting balloon, pta, laser atherectomy and placement of an additional bm3d 7.0 x 150mm stent in the sfa proximal third to middle third on (b)(6) 2022.The recanalisation was reported as successful.The outcome was reported as resolved/recovered.It was reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).The device remains implanted.The event was reviewed on 13-apr-23 by veryan and considered possibly related to the device.It was also considered possibly related to the device by the chief medical officer (cmo) on (b)(6) 2023.
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 7.0 x 60 mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) proximal third in the right leg.A retrograde approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was also post-dilated with pta.The site reported that on (b)(6) 2022, a restenosis of treated segment (target lesion) was identified.The relationship to the device and procedure was reported as not assessable/unknown and due to a worsening pre-existing condition.It was reported as target lesion related and required percutaneous intervention.The patient presented with rest pain in the right foot and rutherford class iv disease.An arterial duplex ultrasound revealed recurrent right sfa occlusion and flow-limiting disease in the right posterior tibial artery.The patient had a known right anterior tibial artery occlusion.Due to the rest pain, the patient was scheduled for urgent right lower extremity angiography and intervention.The patient had pta/standard balloon angioplasty, laser atherectomy and placement of an additional bm3d 7.0 x 150 mm stent in the sfa proximal third to the proximal third peroneal segment on 21-oct-22.The recanalisation was reported as successful.The outcome was reported as resolved/recovered.It was reported as a target lesion/vessel revascularisation (tlr/tvr).The device remains implanted.The event was reviewed on 13-apr-23 by veryan and considered possibly related to the device.It was also considered possibly related to the device by the chief medical officer (cmo) on 16-apr-23.Additional information identified on 11-oct-24, reported that the site had updated the distal segment treated at the intervention from the sfa middle third to proximal third peroneal and they had also removed drug coated/eluting balloon (dcb/deb) treatment from the list of intervention types.
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.The reported patient effects of restenosis leading to intervention and leg pain/claudication are listed in the biomimics 3d instructions for use and are 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.Section b.5.Was updated with additional information, sections g.6.And h.2.Were updated to reflect the type of report (follow-up 02) and the reason, and section h.11.Reflects the sections of the report that were updated.

• 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: 16916609
• Report Number: 3011632150-2023-00064
• Device Sequence Number: 20522231
• Product Code: NIP
• UDI-Device Identifier: 05391526850404
• UDI-Public: (01)05391526850404(17)230922(11)220221(10)0000135829
• 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
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2024

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: 09/22/2023
• Device Model Number: 142122-03
• Device Catalogue Number: 142122-03
• Device Lot Number: 0000135829
• 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: 04/13/2023
• Supplement Date Received by Manufacturer: 07/11/2023; 10/11/2024
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 08/10/2023; 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 146 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American