Model Number 106524 |
Device Problems
Partial Blockage (1065); Material Twisted/Bent (2981)
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Patient Problems
Dyspnea (1816); Fatigue (1849)
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Event Date 01/08/2018 |
Event Type
Injury
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Manufacturer Narrative
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The initial submission of this event was reported by the manufacturer under mfr.Report # 2916596-2018-00898.This report is being submitted as additional information.The heartmate 3 lvas was implanted during the momentum 3 clinical trial, (b)(4).Fda approval for heartmate 3 lvas was received on 23 august 2017.The same device is used commercially and in the ongoing momentum 3 trial.The gtin unique device identifier for the commercial heartmate 3 lvas is (b)(4).Approximate age of device ¿ 4 months.Manufacturer's investigation conclusion: although the evaluation of the submitted log files confirmed the report of low flow alarms, a specific cause for the events could not be conclusively determined through this evaluation.The report of an outflow graft kink could not be confirmed as no images or product were provided for evaluation.In addition, a direct correlation between heartmate 3 lvas, serial number (b)(4), and the reported events could not be conclusively established.The submitted controller event log file captured several transient low flow fault flags throughout the approximately 35 minutes of data, corresponding with the calculated flow reaching values below the low flow threshold of 2.5 lpm.A total of 40 low flow hazard alarms, which lasted between approximately 1 second and 160 seconds in duration.In addition, the submitted controller periodic log file captured low flow fault flags on (b)(6) 2018.Despite the observed alarms, the pump appeared to have functioned as intended throughout the duration of the data.The patient remains ongoing on (b)(4); however, the patient had further low flow issues in (b)(6) 2018 (cs-104933), (b)(6) 2018 (cs-111565), and (b)(6) 2018 (cs-112303).The heartmate 3 lvas ifu lists right heart failure as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.This document 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.This document also 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.In addition, this ifu discusses the potential development of right heart failure following implant and outlines the associated treatment options.Right ventricular dysfunction, especially when combined with elevated pulmonary vascular resistance, may limit the effectiveness of the left ventricular assist system due to reduced filling of the pump.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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Event Description
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The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017.It was reported that the patient was admitted on (b)(6) 2018 for dyspnea and fatigue.Low flow alarms were produced by the lvad.On (b)(6) 2018 right heart catheterization with ramp study found minimal change with speed adjustments there were continuous low flow alarms throughout procedure.A ct angiogram found that the lvad inflow cannula, outflow graft, and driveline were in regular position, and free from thrombus.However the distal anastomosis of the outflow graft had focal kinking with approximately 50% cross-sectional area reduction at the site of kinking.It was also observed that the inflow cannula tip appeared to be moderately obstructed at end systole secondary to near obliteration of the left ventricle (lv) cavity at the cannula tip.There was also diastolic leftward shift of the interventricular septum secondary to marked right ventricular (rv) enlargement and apparent rv volume overload, all of which reportedly likely contributed to hemodynamic compromise.The patient¿s treatment included increase of milrinone 0.3mcg/kg/min, silencing low flow alarms for 4 hour period if needed, and plan for picc when inr allowed warfarin per pharmacy.It was reported that the patient was discharged on (b)(6) 2017.It was also reported on (b)(6) 2018 that the patient had intermittent low flow alarms nearly since implant and was asymptomatic.Milrinone was increased for right heart failure, as was previously reported.Subsequently inotrope was decreased post-right heart catheterization (rhc).Rhc found adequate flow in the outflow graft (ofg).Revatio was also discontinued and multiple fluid boluses were administered.Lvad flow remained in the 3 lpm range.
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Manufacturer Narrative
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Section d5, d10, e4, h4: correction.Updated manufacturer's investigation conclusion: the relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The relevant sections of the device history records for the percutaneous lead were also reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on (b)(6) 2017.The report of an outflow graft kink could not be confirmed through this evaluation; however, they could have contributed to the report of low flow alarms, which were confirmed through the evaluation of the submitted log files.In addition, a direct correlation between heartmate 3 lvas, serial number (b)(6), and the reported events could not be conclusively established.The submitted controller event log file captured a total of 40 low flow hazard alarms throughout the approximately 35 minutes of data on (b)(6) 2018, associated with the calculated flow intermittently decreasing below the low flow threshold of 2.5 lpm.These alarms lasted up to approximately 160 seconds in duration, and calculated flow was captured at values as low as 2.1 lpm.The submitted controller periodic log file captured an additional low flow hazard alarm on (b)(6) 2018 at 07:13:00 am; however, the duration of this alarm could not be determined through this evaluation.Despite the observed alarms, the pump appeared to have functioned as intended throughout the duration of the data.The account communicated that the patient was admitted on (b)(6) 2018 for dyspnea and fatigue.The patient was experiencing low flow alarms, had shortness of breath while walking to the bathroom or performing activities, and had a net negative intake and outtake.A right heart catheterization with ramp study was performed on (b)(6) 2018, which revealed adequate flow in the outflow graft.The patient¿s speed remained at 5000 rpm.The patient had continuous low flow alarms throughout the procedure.A cta performed on (b)(6) 2018 revealed that the lvad pump inflow cannula, outflow cannula, and driveline were in regular position and free from thrombus.Additionally, visual inspection of the submitted ct images did not conclusively reveal evidence of outflow graft kinking.However, it was reported that the anastomosis of the outflow cannula had focal kinking with approximately 50% cross-sectional area reduction (approximately 2 sq cm to 1 sq cm).In addition, the inflow cannula tip appeared to be moderately obstructed at the end of systole secondary to near obliteration of the left ventricular cavity at the cannula tip.There was also a diastolic leftward shift of the intraventricular septum secondary to marked right ventricular enlargement and apparent right ventricle volume overload, all of which likely contribute to the patient¿s hemodynamic compromise.The patient received increased milrinone of 0.3 mcg/kg/min and the low flow alarms were silenced for 4 hours as needed.The patient also received a picc when inr allows warfarin per the pharmacy.It was later reported that revatio was discontinued, and multiple fluid boluses were administered.The patient¿s flow was remaining in the 3¿s lpm.The patient remained ongoing on (b)(6) following this event; however he ultimately expired on (b)(6) 2018.(b)(6) was not returned; there is no product available for investigation.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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