It was reported that on (b)(6) 2016, the patient had experienced a myocardial infraction and had a 4.0x23mm xience prime stent implanted in the right coronary artery (rca).On (b)(6) 2022, the patient enrolled in the ifocus registry and percutaneous transluminal coronary angioplasty was performed in the ramus / rca.On (b)(6) 2023, the patient began to experience chest pain and angiogram revealed stenosis.The patient was treated with a drug eluting balloon.There was no adverse patient sequela and no 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 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 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.The reported patient effects of angina and stenosis are listed in the xience prime, xience prime small vessel (sv), and xience prime long length (ll), everolimus eluting coronary stent systems instructions for use as a known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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