Patient id: (b)(6).It was reported that the procedure was performed on (b)(6) 2020, treating a target lesion in the mid left anterior descending (lad) artery.The 3.0 x 38 mm xience xpedition stent was implanted.On (b)(6) 2022, the patient presented to the emergency room with sudden onset of chest pain.Electrocardiogram was performed and cardiac enzymes were drawn, which were elevated.The patient was admitted for further management.Coronary angiogram was performed.In-stent thrombosis was noted and enoxaparin was administered.Treatment was medication and the event resolved on (b)(6) 2022.No additional information was provided.
|
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 thrombosis are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use (ifu) 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.
|