The catalog number identified has not been cleared in the us but is similar to the e-luminexx vascular stent - mt-6f-zvm 7/ 60/80 products that are cleared in the us.The pro code and 510k number for the e-luminexx vascular stent - mt-6f-zvm 7/ 60/80 products is identified.As the lot number for the device was provided, a manufacturing review will be 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 instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiry date (07/2021).Device not returned.
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It was reported that during a stent placement procedure, to treat lesion in the left external iliac artery using a contralateral approach, the catheter was allegedly unable to cross the lesion.The procedure was completed using another device.There was no reported patient injury.
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