Model Number CPHV |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Death (1802); Thrombosis (2100); No Information (3190)
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Event Date 01/24/2020 |
Event Type
Death
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Event Description
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On (b)(6) 2019 a patient received a carbomedics top hat s5-023 as part of an avr.The manufacturer was notified that the device was explanted on (b)(6) 2020 and replaced with a second carbomedics s5-023.No further information was received.
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Event Description
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On (b)(6) 2019 a patient received a carbomedics top hat s5-023 as part of an avr.The manufacturer was notified that the device was explanted on (b)(6) 2020 and replaced with a second carbomedics s5-023.No further information was received.The manufacturer received the following additional information from the site.The reason for the explant was thrombosis secondary due to patient stopping coumadin.No device malfunction occurred and the explanted device was discarded after the procedure.Patient outcome was death.
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Manufacturer Narrative
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The manufacturer received the following additional information from the site.The reason for the explant was thrombosis secondary due to patient stopping coumadin.No device malfunction occurred and the explanted device was discarded after the procedure.Patient outcome was death.Based on the additional information received from the site the valve thrombosis was a result of a change in the patients medication, stopping of coumadin.The site identified no valve malfunctions occurred.Based on this site assessment no further investigations will be performed and the root cause of the reported issue is deemed to be cause cannot be traced to device : adverse event related to patient condition.
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Search Alerts/Recalls
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