Model Number MV-F401727 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
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Event Date 12/02/2020 |
Event Type
Injury
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Manufacturer Narrative
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A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was implanted in the patient and not returned to the manufacturer for analysis.Additionally, procedural images were not provided for review; therefore, the reported event cannot be confirmed.The instructions for use identifies thrombosis as a potential complication associated with use of the device.
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Event Description
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It was reported that after deployment of the fred in the internal carotid artery, the middle cerebral artery (mca) became occluded.Effient, argatroban, and tpa were administered to the patient, which improved flow in the mca.There was no reported device malfunction of the fred.There was no reported sequela.
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Manufacturer Narrative
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Additional information provided indicated the fred was placed in the a1 to the internal carotid artery without incident.Thrombotic occlusion occurred in the m1 segment, outside the fred.There was no in-stent thrombosis.The patient was reported to have died two weeks later from a cerebral hemorrhage and edema.There was no alleged relationship of the fred to the patient's death.
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Search Alerts/Recalls
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