It was reported that during treatment of a cavernous ophthalmoplegic aneurysm in the right internal carotid artery, a non-microvention flow diverter was delivered through the headway 27 microcatheter and implanted.Treatment was reported to be successful; however, the patient's condition worsened after 24 hours.An mri demonstrated granulomas and complete occlusion of the right hemisphere.The granulomas were surgically removed from the patient and analysis of the granulomas revealed particles of ptfe.The patient was transferred to rehabilitation.No further information has been provided about the patient's current condition.
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Corrected data: (date of event) - the sales representative informed microvention on 7/9/19 that the actual date of occurence is 10/20/2018, not 2/13/19 as initially reported.Device evaluated by mfr: the device, as reported in the initial mdr, was not returned, but additional findings were added to the invesitgation: the complaint noted that the granulomas excised from the patient under microscopic examination contained what appeared to be particles of ptfe.The customer did not supply these microscopic images, and there was no material analysis completed by the customer that confirmed the particles were ptfe.Additionally, multiple devices were used during the procedures, some of which also may have pfte coatings in addition to the headway.As a result of the headway device not being available for analysis, other potential sources of ptfe being used during the procedure, and the lack of confirmation by material analysis that particles are made of pfte, the headway device being the source of the ptfe like particles cannot be verified.
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