Device Problem
Obstruction of Flow (2423)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 09/03/2021 |
Event Type
Injury
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Manufacturer Narrative
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Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
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Event Description
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The following was reported to gore: on an unknown date a patient presented with an unknown etiology in the carotid artery and underwent treatment utilizing a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) device.At an unknown time later the vbx device was reported as possibly thrombosed.Further information has been requested but has not been made available.Event date is unknown, so date gore aware is currently being used instead.Case 2 of 2.
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Event Description
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The following was reported to gore: on (b)(6) 2020, a patient presented with an unknown etiology in the carotid artery and underwent treatment utilizing a 5mm x 29mm gore® viabahn® vbx balloon expandable endoprosthesis (vbx) device.On (b)(6) 2021, the vbx device was reported as possibly thrombosed.
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Search Alerts/Recalls
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