Catalog Number 106524INT |
Device Problems
Kinked (1339); Infusion or Flow Problem (2964)
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Patient Problem
Complaint, Ill-Defined (2331)
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Event Date 03/05/2018 |
Event Type
Injury
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Manufacturer Narrative
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Fda approval for heartmate 3 lvas was received on 23 august 2017.The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4).Approximate age of device ¿ 1 year and 11 months.The patient remains ongoing on lvad support.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) on (b)(6) 2016.It was reported that the patient was admitted to the hospital due to poor general condition.The patient subsequently experienced a low flow situation.A ct scan was performed a twisted outflow graft was suspected.On (b)(6) 2018, a surgical revision of the outflow graft was performed.The bend relief was released and the outflow graft was inspected, with no twisting or kinking observed.The bend relief was attached again and the pump was fixed with sutures.The pump was reportedly working as expected and the patient was moved to the intensive care unit in stable condition.No additional information was provided.
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Manufacturer Narrative
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The device remains in use and was not available for evaluation.The reported event of outflow graft distortion could not be conclusively determined through this evaluation.Moreover, the reported low flow alarms could not be confirmed because no log files from the time of the reported event are available.The referenced ct scan was submitted for review; however, a potential twist in the outflow graft could not be identified via the ct image.Moreover, the submitted photographs showing the proximal end of the implanted outflow graft from the time of the surgical revision did not show any evidence of twisting or kinking of the small visible portion of the outflow graft material extending from the graft attachment.The heartmate 3 lvas instructions for use (ifu) contains information on preparing the sealed outflow graft and instructs the user to verify that the graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief and ensuring that the line is straight.In addition, the ifu outlines all pump parameters, provides information regarding the assessment of pump flow, and outlines all system controller alarms and the appropriate actions associated with each alarm condition.The patient remains ongoing on heartmate 3 lvas and no further events have been reported.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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Event Description
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Additional information: clarification of the event was provided indicating that the reduction of performance was due to constriction of the outflow graft and torquation/mechanical constriction from the outside.After surgical revision of the outflow graft, with removal of fibrin material in the region of the outflow graft, normalization of pump parameters and good flow was achieved.No additional information was provided.
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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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Search Alerts/Recalls
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