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Model Number 106524
Device Problems Partial Blockage (1065); Material Twisted/Bent (2981)
Patient Problems Dyspnea (1816); Fatigue (1849)
Event Date 01/08/2018
Event Type  Injury  
Manufacturer Narrative
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.
Event Description
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 (Section D)
6035 stoneridge drive
pleasanton CA 95488
Manufacturer (Section G)
6035 stoneridge drive
pleasanton CA 95488
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
MDR Report Key7846003
MDR Text Key119220631
Report Number2916596-2018-03744
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Model Number106524
Device Catalogue Number106524
Device Lot Number6036878
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/05/2018 Patient Sequence Number: 1