It was reported in a meeting abstract that the patient developed acute heart failure and was diagnosed with very severe aortic stenosis.After multiple procedures were performed, a 4.0x33 mm xience skypoint stent was advanced from inside a newly implanted transcatheter aortic valve.Pericardial fluid was noted as increasing gradually during the intervention and the blood pressure decreased.Moreover, an ascending aortic dissection was noted by post-percutaneous coronary intervention (pci) aortogram.An emergency thoracotomy was performed.After removal of the stent delivery system, a procedure was performed to replace part of the aorta and the aortic valve.After the procedure, the patient was transferred to a rehabilitation facility until discharge home.The xience skypoint sds functioned as intended; however it is unknown if the stent caused or contributed to the patient effects.No additional information was provided.
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Date of event/procedure will be estimated as (b)(6) 2022.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 effect(s) of hypotension, pericardial effusion and perforation is listed in the xience skypoint 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 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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