It was reported that the procedure was to treat a mildly tortuous, moderately calcified, and 78% stenosed left anterior descending artery.On (b)(6) 2014, pre-dilatation was performed with a 2.5 x 15 mm nc trek balloon catheter and a 2.5 x 23 mm xience xpedition was deployed.Post-dilatation was performed and intravascular ultrasound was performed to complete the procedure.There was no clinically significant delay in procedure and no adverse patient effects.On (b)(6) 2014, the patient was admitted with respiratory discomfort.St elevation was noted.Angiography revealed thrombosis in the implanted stent.Aspiration was performed and an unknown stent was implanted to treat the thrombosis.As of (b)(6) 2014, the patient remains in the hospital and the thrombosis is resolving.No additional information was provided.
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(b)(4).Concomitant products: guide wire: runthrough; guide cath: heartrail 6fr sl3.5.It was not possible to perform a thorough analysis on the product because it was not returned for investigation.In this case, there were no reported device malfunctions or product deficiencies.The reported patient effects of coronary or stent thrombosis and (prolonged) hospitalization are listed in the xience xpedition everolimus eluting coronary stent system instructions for use (ifu) as known patient effects of coronary stenting procedures.Although a conclusive cause for the reported patient effects and the relationship to the device if any cannot be determined, there is no indication of a product quality deficiency with respect to manufacture, design, or labeling.
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