Model Number 106524INT |
Device Problems
Mechanical Problem (1384); Infusion or Flow Problem (2964)
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Patient Problems
Pneumonia (2011); Thromboembolism (2654); Thrombosis/Thrombus (4440)
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Event Date 03/27/2022 |
Event Type
Injury
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Event Description
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It was reported that on 27apr2022 that the patient with heartmate 3 as isolated right ventricular assist device (rvad) support was admitted to the hospital with ¿0,0 lpm¿ flow on the system monitor.At the time of call, the patient was hemodynamically stable.The downloaded log files showed continuous low flow from 16apr2022 to 27apr2022.The hospital also confirmed low flow episodes from 27mar2022 and not specific issues with maintaining oral anticoagulation.The hospital updated that there was no sign of infection or hemolysis.The patient's labs were lactate dehydrogenase (ldh) of 220 u/i, international normalized ratio (inr) of 2.3, activated partial thromboplastin time (aptt 51.3, hemoglobin 97 g/l, red blood cell count 3.23, hematocrit 28, and platelet count was 212.The patient was initiated on iv (intravenous) heparin, agrastat and tbl sintron.A computed tomography (ct scan) was performed on 27apr2022 that showed massive pulmonary thromboembolic event.On 27apr2022 in the afternoon the flow was within range of 3.9-4.4 lpm, pulsatility index was approximately 2.8, and pump power was around 2.9 with unchanged speed of 4400 rpm.
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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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Manufacturer Narrative
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Manufacturer's investigation conclusion: the reported outflow graft thrombus could not be confirmed through this evaluation.Furthermore, a direct correlation between the device and the reported pulmonary thromboembolic event could not conclusively be determined through this evaluation.The submitted system controller event log file contained data from (b)(6) 2022 through (b)(6) 2022.Constant low flow alarms were observed from the beginning of the file until (b)(6) 2022 at 09:46:32, when the flow returned to 2.8 lpm approximately 3 seconds following the last low flow alarm.Although a specific cause for the low flows could not conclusively be determined through this evaluation, the account attributed the event to thrombus within the outflow graft.The pump appeared to operate as intended at the set speed.The relevant sections of the device history records for mlp-016914 were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 03jun2019.Review of the sterilization and packaging documentation in the device history records found no deviations from manufacturing specifications.It was reported that the heartmate 3 left ventricular assist system (lvas), serial number (b)(6) was used as a right ventricular assist device (rvad) which is not an approved indication.The heartmate 3 is indicated for left ventricular assist device (lvad) support, and all labeling, physician training and customer marketing materials are aligned with this indication.The heartmate 3 lvas instructions for use (ifu) is currently available.Section 1 of this document lists peripheral thromboembolic event and infection as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Furthermore, the ifu lists thromboembolism as a potential late postimplant complication.Section 1 of the ifu provides an explanation of all pump parameters, including flow.Section 4 "system monitor" provides information about the pump flow display and the low flow hazard alarm.This section states that the low flow hazard alarm will be triggered when the estimated pump flow is less than 2.5 liters per minute (lpm).The ifu explains that changes in patient conditions can result in low flow.Section 6 provides information regarding anticoagulation, including recommended international normalized ratio (inr) values, and the suggested anticoagulation modifications.Section 7 ¿alarms and troubleshooting¿ describes all alarm conditions, including the low flow hazard, as well as the appropriate actions associated with them.Care instructions in regard to preventing infection are provided in various sections of the ifu, including controlling infection.The heartmate 3 lvas patient handbook is also currently available.Section 5 "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.This document instructs the user that in the event of a low flow hazard alarm, call your hospital contact immediately for diagnosis and instructions.This document contains information about preventing infection.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 hospital confirmed low flow episodes on (b)(6) 2022.The cause of the low flow alarms was the thrombus in the outflow graft.At the time of low flow patient was without any symptoms.The patient was discharged from hospital on (b)(6) 2022.
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Manufacturer Narrative
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Manufacturer's investigation conclusion: the reported outflow graft thrombus could not be confirmed through this evaluation.Furthermore, a direct correlation between the device and the reported pulmonary thromboembolic event could not conclusively be determined through this evaluation.The submitted system controller event log file contained data from (b)(6) 2022.Constant low flow alarms were observed from the beginning of the file until on (b)(6) 2022 at 09:46:32, when the flow returned to 2.8 lpm approximately 3 seconds following the last low flow alarm.Although a specific cause for the low flows could not conclusively be determined through this evaluation, the account attributed the event to thrombus within the outflow graft.The pump appeared to operate as intended at the set speed.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 03jun2019.Review of the sterilization and packaging documentation in the device history records found no deviations from manufacturing specifications.It was reported that the heartmate 3 left ventricular assist system (lvas), serial number: (b)(6) was used as a right ventricular assist device (rvad) which is not an approved indication.The heartmate 3 is indicated for left ventricular assist device (lvad) support, and all labeling, physician training and customer marketing materials are aligned with this indication.The heartmate 3 lvas instructions for use (ifu) is currently available.Section 1 of this document lists peripheral thromboembolic event and infection as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Furthermore, the ifu lists thromboembolism as a potential late postimplant complication.Section 1 of the ifu provides an explanation of all pump parameters, including flow.Section 4 "system monitor" provides information about the pump flow display and the low flow hazard alarm.This section states that the low flow hazard alarm will be triggered when the estimated pump flow is less than 2.5 liters per minute (lpm).The ifu explains that changes in patient conditions can result in low flow.Section 6 provides information regarding anticoagulation, including recommended international normalized ratio (inr) values, and the suggested anticoagulation modifications.Section 7 ¿alarms and troubleshooting¿ describes all alarm conditions, including the low flow hazard, as well as the appropriate actions associated with them.Care instructions in regard to preventing infection are provided in various sections of the ifu, including controlling infection.The heartmate 3 lvas patient handbook is also currently available.Section 5 "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.This document instructs the user that in the event of a low flow hazard alarm, call your hospital contact immediately for diagnosis and instructions.This document contains information about preventing infection.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 patient did not respond adequately to the anticoagulant therapy from the initial day of implant.The patient had pituitary adenoma surgery few years ago.Afterward, the patient was on constant hormonal and corticosteroid therapy.The patient¿s doctors assume it was related to the event.The account stated that the cause of the low flows was due to thrombus in the outflow graft.The thrombus was partially resorbed after anticoagulation therapy in the hospital, which led to pulmonary thromboembolism.It was also reported that the patient got pneumonia.The account stated that a thrombolytic drug and ramp tests helped, and the flow was reestablished suddenly after the thrombus was partially resorbed.After the event, all pump parameters were stable.The patient was hemodynamically stable throughout the duration of the hospitalization and was ultimately discharged from the hospital.After the next hospital check-up, the account stated that the patient was at home and no problems had been reported after the follow-up visit.
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Search Alerts/Recalls
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