Manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the physical sample was not returned to the manufacturer for evaluation.Therefore, the investigation is inconclusive, as no objective evidence has been provided to confirm any alleged deficiency with the device.A definitive root cause could not be determined based upon the available information.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 one month post index procedure, the patient developed 70% of target lesion stenosis.A standard percutaneous transluminal angioplasty (pta) was used to successfully treat the target lesion.The current patient status was not provided.
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