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.A conclusive cause for the reported patient effect of dissection, 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.Dissection is listed in the xience prime everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported this was a procedure to treat a moderately calcified, moderately tortuous de novo lesion in the left anterior descending artery.A xience prime 3.0 x 38mm drug eluting stent (des) was inserted and deployed.However, after deployment, a proximal edge dissection was observed.For treatment, an additional xience prime was deployed.There was no clinically significant delay in the procedure.No additional information was provided.
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