Model Number 106524US |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Ischemia Stroke (4418)
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Event Date 03/03/2022 |
Event Type
Injury
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Manufacturer Narrative
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No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
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Event Description
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It was reported that the patient was diagnosed with a cerebrovascular accident (cva) on (b)(6) 2022.The patient had an acute left parietal and temporal ischemic cva in the setting of an sylvian (m2) segment occlusion.The patient had some dysphagia and right sided weakness.No tissue plasminogen activator (tpa) was given and the patient had no residuals.
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Manufacturer Narrative
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Manufacturer's investigation conclusion: the pump remains in use supporting the patient.A correlation between the device and the report of stroke could not be conclusively determined.Stroke is listed in the instructions for use as a potential adverse event that may be associated with the use of heartmate 3 left ventricular assist system.Stroke has been previously investigated and will continue to be monitored through quality data reviews, which are conducted on production and post product signals to evaluate if products are conforming to product requirements.No further information was provided.The manufacturer is closing the file on this event.
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Event Description
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It was reported that the stroke occurred immediately post operation so no anticoagulation had been started.There was no treatment and no residual symptoms.The symptoms fully resolved.
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Search Alerts/Recalls
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