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.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the heavily calcified and heavily tortuous artery causing the reported failure to advance and subsequent material separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that the procedure was performed to treat a lesion in the heavily calcified, heavily tortuous mid left anterior descending coronary artery.A 2.5x48mm xience xpedition stent delivery system (sds) failed to cross due to the anatomy, and the shaft separated.The device was simply withdrawn, and two non-abbott stents were used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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