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.
|
This is the same case as mdr id 3011632150-2019-00042.The patient was treated as part of the (b)(6) study on (b)(6) 2015.At index procedure ((b)(6) 2015), the patient presented with a de-novo occlusion located in the distal superficial femoral artery (sfa) of the left leg.Two biomimics 3d stents were implanted.On (b)(6) 2019 restenosis of the left distal sfa was reported.Patient had office visit (b)(6) 2019 where he was given an option for conservative medical management with exercise therapy and repeat duplex doppler study, but patient elected to undergo angiography intervention directly.The patient has recovered.The device remains implanted.
|