Product complaint # (b)(4).Information regarding patient weight, height, race, and ethnicity was not reported.Patient identifier: (b)(6).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
|
As reported via the membrane study, an (b)(6) male (subject (b)(6) with a history of a head injury within the past 12 months, hydrocephalus, and smoking underwent middle meningeal artery (mma) embolization of a right subdural hematoma (sdh) on (b)(6) 2022.The patient was randomized into the surgery + mma embolization cohort of the study.His baseline glasgow coma scale (gcs) score was 14, mini mental state exam (mmse) score was 12, markwalder grading scale (mgs) score was 2 and modified rankin scale (mrs) score was 2.The hematoma thickness was 18.3 mm on the baseline ct scan.Surgery was performed on (b)(6) 2022.One burr hole was drilled into the right side of the frontal and parietal skull and a subgaleal drain was placed.The mma embolization study procedure was performed on (b)(6) 2022 using right femoral access.Trufill n-bca 1x1 gram (631500/jd4687) (4:1 oil: n-bca ratio) was delivered via a headway duo microcatheter (microvention).The anterior & posterior branches of the mma were embolized.There was no vasospasm noted during the procedure.In the opinion of the treating physician, the embolization was successful.Additional information received indicated that patient experienced post-anesthesia agitation, which was treated with 195 ug of dexmedetomidine and two-point restraint.The patient recovered and event was resolved on (b)(6) 2022.The principal investigator-assessed this event as moderate in severity, non-serious, not related to the study device, probably related to the mma embolization procedure with n-bca, not related to the sdh medication or to the surgical procedure used to treat the sdh.
|
Product complaint # (b)(4).The adverse event ¿distress (e020203)¿ does not meet regulatory reporting criteria.The reported event was assessed by the principal investigator-assessed as not related to the device, but probably related to the mma embolization procedure with n-bca, the event meets does not meet mdr reporting criteria.Therefore, no further medwatch reports will be forthcoming.
|