Model Number FRED2513-PMA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 11/19/2020 |
Event Type
Injury
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Manufacturer Narrative
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A search for non-conformances associated with this 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; therefore, the alleged event cannot be confirmed.The instructions for use identifies stent thrombosis and thromboembolic event as potential complications 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 device in the posterior cerebral artery (pca), blood flow was reduced in the distal pac and integrilin was administered.Efforts were made to retrieve the fred from the patient, but they were unsuccessful and the device remains implanted.The patient is currently reported to be "ok" and is recovering.
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Search Alerts/Recalls
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