Model Number 106016 |
Device Problems
Partial Blockage (1065); Infusion or Flow Problem (2964)
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Patient Problems
Death (1802); Hemorrhage, Cerebral (1889); Thrombus (2101)
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Event Date 07/14/2018 |
Event Type
Death
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Manufacturer Narrative
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Approximate age of device ¿ 1 year and 9 months the device is expected to be returned for analysis.It has not yet been received.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 admitted to the hospital on (b)(6) 2018 due to extensive intracerebral bleeding.In order to perform a needed operation at that time, anticoagulation therapy was abandoned.What followed next was reportedly no flow through the pump, indicating a suspicion of pump thrombosis.The pump was stopped on (b)(6) 2018, and the patient subsequently expired on (b)(6) 2018.No additional information was provided.
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Manufacturer Narrative
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No product was returned for evaluation.A correlation between the device and the reported event could not be conclusively determined.Device thrombosis, stroke, bleeding, and death are listed in the instructions for use as potential adverse events that may be associated with use of the heartmate ii left ventricular assist system.No further information was provided.The manufacturer is closing the file on this event.
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Event Description
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Additional information: it was reported by the healthcare professionals that the cause of death was not related to the pump; therefore, the pump would not be returned for evaluation.No additional information was provided.
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Search Alerts/Recalls
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