Device is a combination product.Device evaluated by mfr: the device was not received 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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Same case as mdr id # 2134265-2018-06025.It was reported that patient discomfort and complications occurred.Vascular access was obtained via the radial artery.A promus premier¿ stent was implanted the obtuse margin.After the procedure, upon transportation back to the patient's room, the patient became diaphoretic and was brought back to the catheterization lab.The previously implanted stent was widely patent, however, there was a focal lesion in the right coronary artery (rca) that had been undetected.A promus premier¿ stent was then placed in the rca.After the second stent was implanted, the patient's arm was "frozen" and severely uncomfortable.The patient's current status is okay.
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