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

Model Number 106524US

Device Problem Infusion or Flow Problem (2964)

Patient Problems Dizziness (2194); Hypovolemia (2243); Heart Failure/Congestive Heart Failure (4446)

Event Date 05/16/2022

Event Type  Injury  

Manufacturer Narrative

No additional information has been provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was reported that the patient's log files contained low flow events on (b)(6) 2022.The patient was hypovolemic and had right ventricular dysfunction which had caused the alarms.A right heart catheter (rhc) was ordered.The low flow alarms resolved with fluids.

Manufacturer Narrative

Manufacturer's investigation conclusion: low flow alarms were confirmed via the submitted log file data.According to the account, the low flows were due to hypovolemia and/or right heart failure.A direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported hypovolemia and/or right heart failure could not conclusively be determined.The controller event log file contained data on 16may2022 spanning from 08:30:46 to 11:22:24, per the timestamp.Intermittent low flow events were captured from 08:37:54 to 09:31:28 when the estimated pump flow was calculated to be below the threshold of 2.5 liters per minute (lpm).A total of 4 low flow events persisted for at least 10 seconds, activating low flow alarms.No other notable alarms were captured, and the pump appeared to have been operating as intended.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6), and no further events have been reported at this time.The relevant sections of the device history records were reviewed and showed no deviation from manufacturing or quality assurance specifications.The heartmate 3 lvas instructions for use (ifu), rev.C, contains the following information: section 1 lists right heart failure as an adverse event that may be associated with the use of heartmate 3 left ventricular assist system.Speed, power, flow, and pulsatility are also outlined in this section.Section 4 describes the pump flow display and the hazard alarms.The instructions for use states that the low flow hazard alarm will be triggered when pump flow is less than 2.5 liters per minute (lpm) and explains that changes in patient conditions can result in low flow.Section 6 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." section 7 describes the actions to take in the event of a low flow alarm.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient was dizzy at the time of the low flow alarms.The low flow alarms resolved with oral fluid intake.Per the patient, the low flow alarms only occur first thing in the morning prior to eating/drinking.Right ventricular (rv) dysfunction was confirmed by echocardiogram.A right heart catheterization was later performed on (b)(6) 2022, which revealed normal right and left heart filling pressures.The pump speed was increased to 5200 rotations per minute and was to be increased to 5400 rotations per minute at the next outpatient visit.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSIST) 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: 14594670
• MDR Text Key: 293287017
• Report Number: 2916596-2022-11124
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/15/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7460367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2020
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 85 KG