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.
|
The patient was treated as part of the mimics-3d european post-market observational study on (b)(6) 2017.At index procedure ((b)(6) 2017), the patient presented with a restenotic occlusion located in the middle third of the superficial femoral artery (sfa) of the right leg.A 6.0 x 125 mm biomimics 3d stent was implanted.On 31-jul-2018 angiography revealed in-stent-restenosis in the right sfa.No treatment was planned at the time.On (b)(6) 2019 subject was hospitalised for reintervention (bare metal stent,cutting balloon,dcb/deb,pta,thrombectomy) on the treated segment (ostial to distal third of the sfa).The outcome is now resolved and the patient has recovered.The device remains implanted.
|