Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for evaluation.A review of the lot history record could not be conducted because the part and lot numbers were not provided.The reported patient effects of stenosis and amputation or limb loss (surgical intervention) is listed in the supera instruction for use as known patient effects.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatment(s) appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.Article titled: "tctap a-041 interwoven self-expanding nitinol stent with drug-coated balloon angioplasty for the treatment of severely calcified superficial femoral artery lesions: two-year outcomes.".
|