Catalog Number 106015 |
Device Problem
Partial Blockage (1065)
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Patient Problems
Stroke/CVA (1770); Death (1802)
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Event Date 06/27/2017 |
Event Type
Death
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Manufacturer Narrative
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(b)(4).Approximate age of device- 4 years and 3 months.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 on (b)(6) 2013.It was reported that the patient presented to the hospital on (b)(6) 2017 with facial droop and left sided weakness.A ct scan performed showed an ischemic stroke.The patient had a j tube placed and was discharged to a rehabilitation center on (b)(6) 2017.The patient was readmitted to hospital from rehabilitation center on (b)(6) 2017 to have j tube fixed however the procedure was not performed.Additional information received on 19oct2017 reported that the center did not believe there was an outflow graft occlusion from a computed tomography angiography (cta) however they believed the pump may not have been working properly to support the patient.Patient expired on (b)(6) 2017 after family decided to withdraw support.The pump was not explanted.No additional information was provided.
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Manufacturer Narrative
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A correlation between the left ventricular assist system (lvas) and the report ischemic stroke could not be conclusively determined.The pump was not explanted.No additional information was provided.Stroke is listed in the instructions for use as a potential adverse event that may be associated with the use of heartmate ii left ventricular assist system.A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.
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Search Alerts/Recalls
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