Catalog Number H050040J |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Seroma (2069)
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Event Date 07/14/2021 |
Event Type
Injury
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Manufacturer Narrative
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Additional manufacturer narrative: 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 unknown date in 2021, a gore® propaten® vascular graft and a thoratec vascular access graft were used in a hemodialysis shunt surgery.A design was; left brachial artery - propaten - thoratec - propaten - left basilic vein.The patient was hospitalized for a month in another hospital for cerebral hemorrhage.When the patient returned, a seroma was observed.The seroma was located 4cm from the anastomosis of the artery and was about the size of a ping-pong ball.On (b)(6) 2021, a part of propaten with seroma was replaced with a thoratec vascular access graft.The physician stated that the cerebral hemorrhage that led to the hospitalization and hypoalbuminemia was thought to be the cause of the seroma.The albumin level was 2.6 g/dl.There was no causal relationship between the cerebral hemorrhage and the propaten.
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Manufacturer Narrative
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A1 patient identifier - (b)(6).
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Event Description
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The following was reported to gore: on (b)(6) 2021, a gore® propaten® vascular graft and a thoratec vascular access graft were used in a hemodialysis shunt surgery.The devices were implanted in the left brachial artery with the propaten - thoratec - propaten and ending in the left basilic vein.The patient was hospitalized for a month in another hospital for cerebral hemorrhage.On (b)(6) 2021, a seroma was observed.The seroma was located 4cm from the anastomosis of the artery and was about the size of a ping-pong ball.On (b)(6) 2021, a part of the propaten device with seroma was replaced with a thoratec vascular access graft.
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Manufacturer Narrative
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B7: preexisting conditions.
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Search Alerts/Recalls
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