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 angina and stenosis are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effects 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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It was reported that the patient was admitted on (b)(6) 2021, with angina, and underwent a coronary stenting procedure with implant of a 3.0 x 28 mm xience sierra stent in the bifurcation lesion in the proximal third of the posterior descending coronary artery.It was reported that the kissing balloon technique was not performed.On (b)(6) 2024, the patient was re-hospitalized with angina and restenosis was noted in the implanted xience sierra stent.It was unknown if the patient was compliant with dual antiplatelet drug therapy.A non-abbott stent was implanted as treatment of the restenosis.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.
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