This report is related to mdr number : 3011632150-2019-00086.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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This report is related to mdr number : 3011632150-2019-00086.The patient was treated as part of the mimics-3d european post-market observational study on (b)(6) 2018.At index procedure ((b)(6) 2018), the patient presented with a de-novo occlusion located between the ostial of the sfa and the distal third of the sfa in the right leg.Two biomimics 3d stents were implanted.On (b)(6) 2019 reocclusion of the target lesion/vessel was identified.On (b)(6) 2019 percutaneous intervention was performed (stent, dcb/deb, pta, laser/atherectomy, thrombectomy, thrombolysis).
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