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

Catalog Number	142122-06
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	07/11/2023
Type of Reportable Event	Serious Injury
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 left leg, a 6.0 x 80 mm stent which was used to treat a restenotic lesion of the superficial femoral artery (sfa) distal third to proximal popliteal artery.A contralateral approach was used and the lesion was prepared using pre-dilation with a percutaneous transluminal angioplasty (pta) balloon, atherectomy and cutting balloon.The treated segment was post-dilated with pta.The site identified an arterial stenosis (non-target, de-novo) event on 11-jul-23.It was reported as possibly related to the device and not related to the procedure.It was not target lesion related.The left tibioperoneal trunk (tpt) and posterior tibial artery were treated with pta/standard balloon angioplasty on 11-jul-23.The event was treated as part of an intervention on the sfa distal third to posterior tibial proximal third.This intervention also treated an occlusion of the bm3d stent identified on (b)(6) 2023 (mdr 3011632150-2023-00109) and a suspected stent fracture (mdr 3011632150-2023-00085) where a non-bm3d stent was placed.The intervention was reported as a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.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.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 worsening of peripheral arterial disease leading to additional surgical intervention, endovascular intervention or amputation 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
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 left leg, a 6.0 x 80 mm stent which was used to treat a restenotic lesion of the superficial femoral artery (sfa) distal third to proximal popliteal artery.A contralateral approach was used and the lesion was prepared using pre-dilation with a percutaneous transluminal angioplasty (pta) balloon, atherectomy and cutting balloon.The treated segment was post-dilated with pta.The site identified an arterial stenosis (non-target, de-novo) event on 11-jul-23.It was reported as not related to the device and not related to the procedure but was due to a worsening pre-existing condition.It was not target lesion related.The left tibioperoneal trunk (tpt) and posterior tibial (pt) artery were treated with pta/standard balloon angioplasty on (b)(6) 2023.The event was treated as part of an intervention on the sfa distal third to posterior tibial proximal third.This intervention also treated an occlusion of the bm3d stent identified on (b)(6) 2023 and a suspected stent fracture (mdr 3011632150-2023-00085) where a non-bm3d stent was placed.The intervention was reported as a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.The device remains implanted.Additional information reviewed by veryan on 13-may-24 included the clinical events committee (cec) adjudication on this event.It was adjudicated as not related to the device as it was not target lesion related as the event related to the left tpt and pt segments.The previous tlr was reported on mdr 3011632150-2023-00109.
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 cannot be determined.The reported patient effect of worsening of peripheral arterial disease leading to additional surgical intervention, endovascular intervention or amputation 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, section h.2.Were 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 that 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: 18495416
• Report Number: 3011632150-2023-00148
• Device Sequence Number: 15199966
• Product Code: NIP
• UDI-Device Identifier: 05391526850428
• UDI-Public: (01)05391526850428(17)230211(11)210713(10)0000096641
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• 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: 02/11/2023
• Device Catalogue Number: 142122-06
• Device Lot Number: 0000096641
• 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: 12/14/2023
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• 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: CLOPIDOGREL (PLAVIX)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 129 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White