Manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the sample was not returned for evaluation.The investigation is inconclusive, as no objective evidence has been provided to confirm any alleged deficiency with the device.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.
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It was reported through the results of a clinical trial, that approximately five months post index procedure, the patient developed 80 % of target lesion stenosis.A standard percutaneous transluminal angioplasty (pta) was used to successfully treat the target lesion.The patient was expired due to end stage renal disease and the cause of death was not related to the device.
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