Catalog Number 102953 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Infarction, Cerebral (1771); Death (1802)
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Event Date 01/12/2017 |
Event Type
Death
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Manufacturer Narrative
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The referenced driveline infection was reported under medwatch mfr report# 2916596-2016-01464.(b)(4).The approximate age of device: 8 days.(calculated from date of implant to date removed) the device will not be returned for evaluation.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.
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Event Description
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The patient was implanted with a left ventricular assist device (lvad).It was reported that the patient was explanted due to chronic driveline infection and recurrent bacteremia.The patient was then supported by an extracorporeal circulatory support device; however, the patient experienced a severe ischemic stroke and expired on (b)(6) 2017.
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Manufacturer Narrative
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A correlation between the device and the reported driveline infection and ischemic stroke could not be conclusively determined.Driveline infection and stroke are listed in the instructions for use as potential adverse events that may be associated with the use of the heartmate ii left ventricular assist system.A review of the device history records, including the sterilization and packaging documentation, found no deviations from manufacturing specifications.The manufacturer is closing the file on this event.
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Search Alerts/Recalls
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