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Model Number H702496 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Death (1802)
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Event Date 10/24/2019 |
Event Type
Death
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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The patient expired from a stroke 7 days post-procedure.No additional information is available at this time.Patient's information (e.G.Age, weight, gender, ethnicity, race, patient's initials) cannot be handled by abbott in absence of patient's written consent as required by the personal data protection national legislation.National legislation prevents the recording of such information.A written consent has not been obtained in this case; therefore, this information is not available.
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Manufacturer Narrative
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Correction to the initial report, additional information was received that the death was not related to any abbott devices.An autopsy was performed on the patient and an unknown issue was found with the aorta.Since the devices were never used in the aorta, it was believed that the death was not related to the procedure or any abbott devices.The hospital stated they do not believe the event had anything to do with any abbott devices or the procedure and that there were no issues with any abbott devices.No additional information is available at this time.The results of the investigation are inconclusive since the device was not returned for analysis. review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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