The catalog number identified has not been cleared in the us, but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The pro code for the fluency plus endovascular stent graft products is identified.As the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for evaluation.The investigation is confirmed for misfire, material perforation and positioning failure.A definitive root cause for the reported event could not be determined.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 fvm14080 endovascular stent graft allegedly experienced misfire, material perforation and positioning failure.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The age, sex and weight of the patient were not provided.
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