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 mimics-3d european post-market observational study on (b)(6) 2016.At index procedure, the patient presented with a de-novo occlusion located between the proximal third of the sfa and distal third of the sfa of the left leg.One biomimics 3d stent was implanted.On (b)(6) 2019 restenosis of the treated segment (target lesion) was identified.On (b)(6) 2019, percutaneous intervention was performed (stent, bare metal, drug coated balloon/drug eluting balloon, laser/atherectomy, thrombectomy).The device remain implanted.The event has resolved.
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