MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

Model Number 106524US

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problems High Blood Pressure/ Hypertension (1908); Thrombosis (2100); Ventricular Tachycardia (2132); Heart Failure (2206); Hypovolemia (2243)

Event Date 11/01/2014

Event Type  Injury  

Manufacturer Narrative

Specific patient information not provided.Date of event is approximate as the data were collected between november 2014 and december 2018.Device serial numbers unknown.Author: t.Ogami, et al.¿incidence and cause of persistent low flow alarm after heartmate 3 left ventricular assist device insertion." journal of heart and lung transplantation, volume: 39, issue: 4, pages: s404.Manufacturer's investigation conclusion: a direct correlation between the heartmate 3 left ventricular assist system and the reported events (thromboembolism, hypertension, hypovolemia, right heart failure, cardiac arrhythmia, and low flow alarms) could not be conclusively determined through this investigation.A study conducted by new york-presbyterian/columbia sought to determine the incidence and cause of readmission due to persistent low flow alarms after heartmate 3 left ventricular assist device implantation.The study reviewed 135 patients who were implanted with heartmate 3 left ventricular assist devices between november 2014 and december 2018 at new york-presbyterian/columbia.Patients who required readmission due to persistent low flow alarms were identified and analyzed.A cumulative incidence function curve was constructed to analyze the probability of low flow alarm readmission.Twenty-three patients (17.4%) required 28 readmissions due to persistent low flow alarms with a median follow up of 11.2 months.The incidence of readmissions with persistent low flow alarms was 1.31 person-years.The probability of low flow alarm readmission was 17.7% at 1-year.Of the 23 patients, 4 patients (17.4%) required multiple readmissions.The etiology of the persistent low flow alarms was due to hypovolemia (39.3%), hypertension (17.8%), inflow or outflow obstruction (17.8%), right heart failure (3.6%), ventricular tachycardia (3.6%), and unknown reasons (17.8%).None of the patients had an electrical issue with the pump or a driveline disruption identified.The study concluded that readmission due to low flow alarms is relatively common after heartmate 3 left ventricular assist device implantation.Hypovolemia was the most frequent etiology of low flow alarms.Obstruction of the inflow cannula or outflow graft is a serious complication that can present with low flow alarms and requires reoperation.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) lists thromboembolism, hypertension, right heart failure, and cardiac arrhythmia as adverse events that may be associated with the use of the heartmate 3 lvas.Thromboembolism and cardiac arrhythmia are also listed as potential late postimplant complications that may be associated with the use of the heartmate 3 lvas.The ifu section 4 entitled "system monitor" explains that the low flow hazard alarm will be triggered when pump flow is less than 2.5lpm and states that changes in patient conditions can result in low flow.Section 6 entitled "patient care and management" contains information regarding the recommended anticoagulation therapy and international normalized ratio range.Section entitled 7 "alarms and troubleshooting" outlines all system alarms and the recommended actions associated with them.Additionally, the ifu states: ¿right heart failure can occur following implantation of the pump.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.¿ no further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported through the research abstract ¿incidence and cause of persistent low flow alarm after heartmate 3 left ventricular assist device insertion¿ identifying that the hm3 patients are frequently readmitted due to persistent low flow alarm.A total of 135 patients implanted with hm3 between november 2014 and december 2018 were retrospectively evaluated.The patients who required readmission due to persistent low flow alarms were identified and analyzed.Twenty-three patients (17.4%) required 28 readmissions due to persistent low flow alarms during median follow up of 11.2 months.The incidence of readmissions with persistent low flow alarms was 1.31 person-years.The probability of low flow alarm readmission was 17.7% at 1-year.Of 23 patients, 4 patients (17.4%) required multiple readmissions.The etiology of persistent low flow alarms was: hypovolemia in 11 (39.3%) and hypertension in 16 (17.8%).Inflow or outflow obstruction requiring surgical intervention was present in 5 (17.8%).The reason for the alarm was not identified in 5 patients (17.8%).No electrical pump issue or a driveline disruption was identified.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 10978181
• MDR Text Key: 220532555
• Report Number: 2916596-2020-05890
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention