Device is a combination product.Device evaluated by mfr.:the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).
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It was reported that in-stent restenosis occurred.The patient presented with st segment elevation myocardial infarction.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery (lad).A 2.75 x 28 mm synergy ii drug-eluting stent was implanted in the lad.However, after the procedure, the patient was returned to the lab complaining of chest pain.Another procedure revealed that the stent has restenosed.A 3.0 x 8 mm and a 3.0 x 12 mm non-bsc balloon catheter was used to expand the stent.Optical coherence topography revealed good stent apposition and the procedure was completed.No further patient complications were reported and patient¿s status was well.
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