The lot number for the malfunction was provided and a lot history review will be performed.The device has been returned for evaluation; the evaluation confirmed misfire, fracture, and material perforation.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
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This report summarizes one malfunction.A review of the reported information indicated that model fem08060 endovascular stent graft allegedly experienced fracture, misfire, and material perforation.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient was a 60 year old male; weight was not provided.
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