It was reported that the procedure was performed to treat a lesion in the mid lad with 2.5x28 xience prime stent.During the procedure, a distal edge dissection occurred.A 2.5x15 xience prime stent was deployed to treat the dissection and complete the procedure.The patient experienced mild chest pain; however, symptoms resolved after second stent placement.There were no reported adverse patient sequela.No additional information was provided.
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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.The reported patient effects of dissection and angina are listed in the xience prime, xience prime small vessel (sv), and xience prime long length (ll), everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment 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; therefore, no product-related corrective action will be implemented in this case.
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