The device was not returned for evaluation.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 effect(s) of dissection is 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(s) of coronary stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.However, the 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.
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It was reported that the procedure was to treat a lesion with moderate calcification, moderate tortuosity, and 80% stenosis in the left circumflex artery.A 4.0x33 mm xience prime stent was implanted; however, a proximal edge dissection occurred.Another unspecified stent was implanted to treat the dissection.The procedure was successfully completed with good results.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
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