It was reported that on (b)(6) 2013, a 3.5x23mm and a 3.5x18mm xience prime stent were successfully implanted in the left main complex (left main, ostial left anterior descending (lad), ostial/proximal left circumflex (lcx) coronary arteries).On (b)(6) 2018, the patient had chest pain and went into cardiac arrest and while going to the hospital.The patient was hospitalized and closed cardiac massage (cpr) was provided.A myocardial infarction was diagnosed.During this hospitalization, the patient had hypotensive episodes and pulmonary edema.Medical treatment was provided and a myocardial perfusion scan was provided displaying ischemic dilatation with impaired left ventricular dysfunction.No new restenosis was reported.The event resolved.No additional information was provide regarding this issue.
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(b)(4).There was no reported device malfunction and the product was not returned as the stent remains in the anatomy.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It should be noted that the reported patient effect of angina, hypotension, ischemia, myocardial infarction and pulmonary edema are listed in the xience prime, xience prime small vessel, and xience prime everolimus eluting coronary stent system instructions for use (ifu) as a known patient effects of coronary stenting procedures.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined and the treatment appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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