The device was not returned for evaluation.
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 myocardial infarction, stenosis, thrombosis and hypotension 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.
There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Patient id (b)(6).
It was reported that on (b)(6) 2019, the patient underwent a coronary stenting procedure to treat a lesion in the proximal right coronary artery (rca).
A 3.
25 x 28 mm xience sierra stent was implanted without issue.
On (b)(6) 2020, the patient presented to the emergency room with lightheadedness and stated they had been feeling weak and lightheaded since the stenting procedure.
Additionally, blood pressure was low and cardiac enzymes were elevated.
Myocardial infarction was diagnosed.
Medications were administered.
Cardiology was consulted and angiography was performed, revealing severe in-stent restenosis and thrombosis.
Intravenous ultrasound (ivus) noted prolapsed calcific plaque through the stent struts.
Revascularization was performed on (b)(6) 2020, with angioplasty, stent implantation and aspiration thrombectomy.
The event resolved on (b)(6) 2020.
No additional information was provided.
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