(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).There was no device malfunction and the device did not return.The investigation was unable to determine a conclusive cause for the reported patient effects.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of stenosis and claudication are known potential patient effects as listed in the supera instructions for use.Although a conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined, there is no indication the reported patient effects were caused by or related to the design, manufacture or labeling of the device.
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It was reported that on (b)(6) 2014, the patient underwent a peripheral stenting procedure, with placement of a supera stent in the superficial femoral artery.On (b)(6) 2014, the patient presented with claudication.Angiography was performed and noted restenosis in the supera stent, with restenosis above and below the stent.Balloon angioplasty was performed in the stent, as well as above and below the stent.Final results were good.No additional information was provided.
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