MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SYSTEM CONTROLLER; LVAD SYSTEM CONTROLLER

Catalog Number 106531

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 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 patient remains on lvad support.No additional information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

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 SYSTEM CONTROLLER
• Type of Device: LVAD SYSTEM CONTROLLER
• 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 ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 7291204
• MDR Text Key: 100762291
• Report Number: 2916596-2018-00661
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/22/2018

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: Lay User/Patient
• Device Catalogue Number: 106531
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/22/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 72