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 angina and ischemia are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as 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) 2020 two xience xpedition stents, both 3.
0x48 mm sizes, were implanted in the mid right coronary artery.
On (b)(6) 2020 the patient had angina and was admitted to the hospital.
There was no change to the electrocardiogram.
The troponin levels on (b)(6) 2020 were elevated and were decreasing during the hospitalization.
A myocardial perfusion scan possibly indicated the presence of inferior ischemia.
Medication was administered, a minitran patch.
The condition resolved on (b)(6) 2020.
No additional information was provided.
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