THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, EUROPE; LEFT VENTRICULAR ASSIST DEVICE
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Catalog Number 106524INT |
Device Problems
Partial Blockage (1065); Low Readings (2460)
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Patient Problem
Thrombus (2101)
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Event Date 03/11/2018 |
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 ¿ 6 days.The device was returned for investigation.The evaluation is not yet complete.The patient remains ongoing on lvad support with the replacement device.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) 2018.It was reported that after approximately 6 days of support, a sudden drop in estimated pump flow occurred followed by persistent low flow alarms, confirmed via the system controller log files.In addition, pump power consumption decreased simultaneously.Echocardiography revealed a structure above/on top of the inflow cannula.Reportedly, anticoagulation therapy with heparin was difficult after the initial implant.The patient¿s platelet count decreased quickly from greater than 300000/l to less than 80000/l.A positive heparin induced thrombocytopenia was suspected.The patient was returned to the operating room, and a large occluding blood clot inside the inflow cannula was observed.The outflow cannula and the graft were also affected.The pump and the graft were immediately exchanged and the patient was transferred under stable conditions to the intensive care unit.The new pump performed as expected, and no further issues occurred.No additional information was provided.
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Manufacturer Narrative
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The report of an ingested thrombus was confirmed via the submitted photos and in the evaluation of heartmate 3 lvas.The photos revealed the reported large ingested thrombus formation occluding the inflow cannula.The photos also show depositions of tissue-like blood in the pump outflow and outflow graft due to the lack of flow caused by the ingested thrombus.Upon disassembly of the returned pump, tissue-like clotted blood was observed in the inflow cannula, outflow graft, pump cover and on the pump rotor.The lack of structure of these depositions suggests that they developed acutely, likely due to poor surface washing as a result of the confirmed decrease in flow through the device caused by the ingested thrombus.The device was cleaned, rebuilt, and tested under load conditions on a mock circulatory loop.The pump functioned as intended.Thromboembolism is listed in the instructions for use (ifu) as a potential adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.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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