During the coil embolization procedure for a ruptured middle central artery (mca), it was reported that the coil was prematurely detached during reposition in the aneurysm.Therefore, the detached coil was removed with snare and thrombus was found on the coil.The procedure was successfully completed after replacing with another product.
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The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that the main coil was stretched and prematurely detached inside patient.In addition, the delivery wire was kinked and broken inside patient.As per the additional information, the flush was continuous.While patient thrombus is an anticipated complication it is most likely that anatomical or procedural factors encountered during the procedure contributed the patient vessel thrombosis encountered during the procedure.Therefore, a probable cause of procedural factors will be assigned to the main coil damage and the thrombus, as these defects appear to be associated with a product that met the design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.
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During the coil embolization procedure for a ruptured middle central artery (mca), it was reported that the coil was prematurely detached during reposition in the aneurysm.Therefore, the detached coil was removed with snare and thrombus was found on the coil.The procedure was successfully completed after replacing with another product.
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