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.
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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.
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