MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

Model Number 106524

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Nausea (1970); Weakness (2145); Dizziness (2194)

Event Date 01/24/2018

Event Type  Injury  

Manufacturer Narrative

The initial submission of this event was reported by the manufacturer under mfr.Report # 2916596-2018-00661.This report is being submitted as additional information.The heartmate 3 lvas was implanted during the momentum 3 clinical trial, ide# (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 system controller is (b)(4).The system controller serial number, expiration date, age and manufacturing date is not known.Manufacturer's investigation conclusion: the reports of alarms and disconnection from the system controller could not be confirmed through this evaluation as no log files were provided by the account.The patient remains ongoing on heartmate 3 lvas, serial number (b)(4).No further issues have been reported.The hm3 patient handbook and ifu contain information regarding alarms and troubleshooting, replacing the running system controller with a backup controller, changing power sources, and handling emergencies.The patient handbook includes several warnings regarding disconnecting the driveline, including "the pump will stop if the driveline is disconnected from the system controller.If the driveline disconnects from the system controller, reconnect it right away to restart the pump.The pump cannot run without power." 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 on (b)(6) 2018, the patient¿s spouse was attempting to exchange the ¿module¿, for a new one.The spouse was having difficulty and the ¿module¿ was loose and the device was alarming.The patient became dizzy, lightheaded and very close to losing consciousness but did not faint.However, the son was able to successfully make the connection reattaching to the old controller.The patient was disconnected less than a minute.Once re-attached to the old ¿module¿, the patient felt much better but still felt weak, tired, and nauseous.Prior to this event, the patient was in normal state of health.The patient was admitted and was symptomatically improved by time of presentation.There was no suspicion of lvad thrombosis, sepsis or arrhythmia given timing of the event and rapid improvement.Lactate dehydrogenase was unchanged and hemoglobin was stable, lvad parameters unchanged.The lvad was interrogated by the lvad clinicians and no malfunction was found.Lab values and vital signs were stable.The patient was observed overnight.The patient felt well the next day and was discharged on (b)(6) 2018 without incident except aspirin was lowered to 81 mg daily.The patient had been hospitalized for 16 hours.No additional information was provided.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 7975154
• MDR Text Key: 124065559
• Report Number: 2916596-2018-04547
• Device Sequence Number: 1
• Product Code: DSQ
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Model Number: 106524
• Device Catalogue Number: 106524
• Device Lot Number: 5820573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/17/2017
• 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
• Patient Age: 62 YR
• Patient Weight: 72