This mdr report is related to the following additional mdr report numbers: mdr 3011632150-2019-00114 and mdr 3011632150-2019-00115.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 mdr report is related to the following additional mdr report numbers: mdr 3011632150-2019-00114 and mdr 3011632150-2019-00115.The patient was treated as part of the mimics-3d european post-market observational study on 28-september-2017.At index procedure (28-september-2017), the patient presented with a de-novo occlusion of the segment involving the proximal third of the superficial femoral artery (sfa) and the distal popliteal artery of the left leg.Three biomimics stents were implanted.A 5.0 x 60 mm stent, 6.0 x 125mm stent , and 6.0 x 100mm stent were implanted.On (b)(6) 2018 a restenosis of the treated segment (target lesion) was identified.Percutaneous intervention took place on (b)(6) 2018 and included drug coated balloon / drug eluting balloon and percutaneous transluminal angioplasty / standard balloon angioplasty.The outcome of the event is that it has resolved and patient has recovered.The devices remain implanted.
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