Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.
|
It was reported through the results of a clinical trial, that approximately three months post index procedure, stenosis in target lesion was observed.A standard pta was used to successfully treat the target lesion.The patient was expired due to hyperkalemia and the cause of death was not related to device.
|