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 effects of restenosis leading to intervention and claudication/leg pain 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.
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The patient was enrolled in the mimics 3d usa post-market observational study.On (b)(6) 2022, the patient was implanted with one biomimics 3d (bm3d) 5.0 x 60 mm stent to treat a denovo lesion in the left superficial femoral artery (sfa) distal third.A retrograde approach was used and the lesion was stented and post-dilated with a percutaneous transluminal angioplasty (pta) balloon.On (b)(6) 2023, a restenosis of the treated segment (target lesion) was identified and it was reported as possibly related to the device and not related to the procedure.It was target lesion-related.It was identified at the patient's 12-month follow-up visit.The patient was experiencing rutherford class (rc) 3 symptoms in the left leg.Duplex ultrasound (dus) showed stenosis in the left distal sfa (target lesion).A diagnostic angio on (b)(6) 2023 showed severe in-stent restenosis at (b)(4).An intervention was performed on (b)(6) 2023.A laser atherectomy was performed within the existing stent, followed by drug coated/eluting balloon (dcb/deb).Residual stenosis was less than (b)(4) afterwards.The intervention was a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved recovered.
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