Model Number S5-021 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Endocarditis (1834); No Information (3190)
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Event Date 07/26/2019 |
Event Type
Injury
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Manufacturer Narrative
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Device disposition presently unknown.
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Event Description
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On (b)(6) 2018 a patient received a carbomedics tophat s5-021 mechanical heart valve as part of an avr.The manufacturer was notified that the device was explanted on (b)(6) 2019 and replaced with a s5-023.No further information was received.
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Event Description
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On (b)(6) 2018 a patient received a carbomedics tophat s5-021 mechanical heart valve as part of an avr.The manufacturer was notified that the device was explanted on (b)(6) 2019 and replaced with a s5-023.Additional information received on (b)(6) 2019 identified that the valve was explanted as a result of endocarditis.There were no device malfunctions identified and the patient was discharged without complications.Based on this assessment there is no reasonable information suggesting a relationship between the device and the endocarditis.
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Manufacturer Narrative
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Additional information received on (b)(6) 2019 identified that the valve was explanted as a result of endocarditis.There were no device malfunctions identified and the patient was discharged without complications.Based on this assessment there is no reasonable information suggesting a relationship between the device and the endocarditis.Based on the additional information received there is no reasonable information suggesting a relationship between the device and the endocarditis as the device had no malfunctions, and there were no information included in the follow-up identifying a device relationship.At this time no investigations will be performed and the case will be closed as not device related.The event conclusion is thus cause cannot be traced to device : adverse event related to patient condition.
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Search Alerts/Recalls
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