(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined that the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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It was reported that the procedure was to treat a moderately tortuous, heavily calcified, concentric distal left anterior descending coronary artery.Following pre-dilatation, a guideliner was used to assist a 2.50 x 38mm xience alpine stent delivery system, but was unable to cross due to a heavily calcified lesion.Resistance was met with the lesion during advancement and removal of the device.A non-abbott stent was used to successfully complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
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