There was no reported device malfunction and the device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to 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 claudication and occlusion/restenosis 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 treated as part of the (b)(6) study on (b)(6) 2017.At index procedure ((b)(6) 2017), the patient presented with a de-novo occlusion between the distal third of the superficial femoral artery (sfa) and the proximal popliteal artery of the left leg.A 6.0 x 80 mm biomimics 3d stent was implanted.On (b)(6) 2019 a restenosis of the treated segment (target lesion) was reported to veryan with a date of on set of (b)(6) 2019.On (b)(6) 2019 the patient had a percutaneous intervention on the treated segment.This included bare metal stent, percutaneous transluminal angioplasty / standard balloon angioplasty and thrombectomy.The outcome of the event is that it has resolved and patient has recovered.The device remains implanted.
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