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

Model Number 106524INT

Device Problems Pumping Stopped (1503); Unexpected Shutdown (4019)

Patient Problem Dyspnea (1816)

Event Date 03/07/2022

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient was at home and about to routinely change their driveline wound dressing when the system controller alarmed and displayed "pump off".Emergency services was called and when an ambulance arrived the patient was doing well, but their breathing was noted to be a little worse.The controller was exchanged and the pump started promptly after exchange and the values were back in normal range.The patient recovered quickly and was brought to the clinic for a check-up.Evaluation of log files showed a controller internal fault.The patient was doing well post exchange and was discharged one day after one day of inpatient monitoring.Related manufacturer report number 2916596-2022-01535.

Manufacturer Narrative

Manufacturer's investigation conclusion: evaluation of the submitted log files confirmed a pump stop event that appeared to be due to open fuses in the system controller.A direct correlation between heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6), and the open fuses could not be conclusively established through this evaluation.The controller event log file contained data from 02mar2022 through 07mar2022.On 07mar2022, a controller internal fault alarm was captured, which was followed by a pump stop event.The pump stop event was associated with a vs b low, vs a low fault, and a driveline disconnect alarm.The driveline disconnect event appeared to be due to the open fuses that were confirmed through the evaluation of the returned system controller.A no external power alarm was also captured on 07mar2022 which appeared consistent with the report of a system controller exchange.No other notable events or alarms were captured.Prior to the fuse damage, there were no notable events or alarms captured and the pump appeared to function as intended at the set speed.The patient remains ongoing on hm3 lvas, serial number (b)(6), and no further events have been reported at this time.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 07may2019.The heartmate 3 lvas ifu and the heartmate 3 patient handbook are currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 7 of the ifu, "alarms and troubleshooting", and section 5 of the patient handbook, "alarms and troubleshooting", address all system alarm conditions as well as the appropriate actions associated with each condition.Section 8 of the patient handbook, ¿handling emergencies¿, also provides examples of emergencies and the proper actions to take in the event an emergency occurs.The ifu caution the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.

• 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: 13904811
• MDR Text Key: 287927882
• Report Number: 2916596-2022-01534
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/20/2021
• Device Model Number: 106524INT
• Device Lot Number: 6854724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2019
• 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 Sex: Female