Model Number FRED3009-PMA |
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 12/14/2020 |
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 alleged event cannot be confirmed.The instructions for use identifies stent 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 six days after successful implantation of the fred in the right a1/a2 segment to treat a very small ruptured acom aneurysm, an occlusion of the fred was identified; however, there was collateral flow and the patient was asymptomatic.No additional intervention was performed.There was no reported device malfunction.
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Search Alerts/Recalls
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