The lot number was provided for the reported malfunction; therefore, a lot history review is currently being performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.The catalog number identified has not been cleared in the us, but is similar to the lifestent 5f vascular stent system products that are cleared in the us.The pro code for the lifestent 5f vascular stent system products is identified.
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H10: the lot no for the device was provided, therefore a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the lifestent 5f vascular stent system products that are cleared in the us.The pro code for the lifestent 5f vascular stent system products is identified in d2.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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