Model Number 106015 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Right Ventricular Dysfunction (2054)
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Event Date 02/18/2020 |
Event Type
Injury
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Manufacturer Narrative
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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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It was reported per the ventricular assist device (vad) coordinator, the patient underwent heart transplant.On (b)(6) 2020 patient with right ventricular (rv) dysfunction.Heart list changed to status 2.The device will not be returned for evaluation.
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Manufacturer Narrative
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Section h1: report type was incorrectly listed as patient death in the initial report.Manufacturer's investigation conclusion: a direct relationship between the device and the reported right ventricular dysfunction could not be conclusively determined through this evaluation.The account reported that the patient was upgraded to status 2 on the transplant list due to right ventricular dysfunction.The patient underwent a heart transplant on (b)(6) 2020 and the pump was not returned for evaluation.The heartmate ii lvas ifu lists right heart failure as an adverse event that may be associated with the 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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Search Alerts/Recalls
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