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.Device not returned.
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It was reported through the results of a clinical trial, that subject had an adverse event of rash and itching related to study procedure and recovered.Approximately three months post index procedure, the patient developed 50% 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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