It was reported that the procedure was to treat a de novo lesion located in the left anterior descending coronary artery that was both moderately calcified and tortuous.Reportedly, post deployment of the xience alpine des 3.00x23 rx stent and post dilatation with a non-compliant balloon, a dissection was observed.A xience alpine 3.0x12mm was used as treatment with good result shown in the angiogram with timi iii flow.There was no adverse patient sequelae and no reported clinically significant delay in the procedure.No additional information was provided.
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The device was not returned for analysis.A review of the corrective and preventive actions (capa) database was performed and revealed no related complaint assessment nonconformities.The electronic lot history record (elhr) revealed no associated manufacturing nonconformities issued to the reported lot.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.A conclusive cause for the reported patient effect(s), 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.The reported patient effect of dissection is listed in the xience alpine everolimus eluting coronary stent system (eifu), electronic 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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