The events are part of a retrospective study.Dissection, vessel perforations and embolization required intervention is captured.As the lot numbers for the devices were not provided, a manufacturing review could not be performed.The samples were not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported events is inconclusive.Based upon the available information, the definitive root cause for these events 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.
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It was reported in a post-market clinical follow-up survey on pta balloon dilatations, 25 dissections, 15 vessel perforations and 10 distal embolization occurred.It was further reported that the medical intervention was required to treat the patients.The current patients' status is unknown.
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