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

Model Number 106524INT

Device Problems Failure to Power Up (1476); Electro-Static Discharge (2149); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2022

Event Type  Injury  

Manufacturer Narrative

(b)(6).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's device had a electrostatic discharge (esd) while unwrapping a new mattress at home.The patient noticed a short irregularity from the pump and the controller did not display any pump parameters anymore.The patient performed a successful controller self-test - display remained dark and pump running symbol was green active.The controller showed a lvad fault alarm with 17l flow at 15 watts, 5400 rotations per minute, and 2.2 pi.The pump had restarted followed by high power consumption and temperature.The controller was exchanged (b)(6) 2022 in the operating room.The pump did not restart automatically and it would not manually start via system monitor.High power consumption observed.The pump was immediately exchanged with the backup implant kit.Related manufacturer report number # 2916596-2022-00435.

Event Description

It was reported that the event resolved after pump exchange, and the patient was doing well.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event was confirmed based on the evaluation of (b)(6) and the submitted log files.The submitted system controller log file showed the pump operating at the set speed of 5400rpm with power elevated to approximately 20w and the flow estimation approximately 18lpm.An lvad fault alarm was active due to the pump temperature being elevated to 70 celsius.The onset of these elevated parameters had been overwritten by newer data, however, the lvad event log file showed a pump reset at 12:05 on (b)(6)2022, which appeared to be consistent with the report of the patient experiencing electrostatic discharge (esd).Following this event, the pump data showed the current draw become elevated from baseline, resulting in an increase in pump temperature and flow estimation.The rotor levitation values appeared comparable to the values from before the pump reset.(b)(6) was returned with the pump cable cut approximately 4¿ from the pump housing and the severed portion was not returned.The apical cuff, sealed outflow graft, and modular cable were also not returned.Examination of the pump blood-contacting surfaces found no depositions or thrombus formations.After cleaning, the pump was connected to a test system controller.The pump did not start.The lvad log files were able to be downloaded and all of the captured data appeared consistent with the pump attempting to restart both in the or and when connected to the test controller.The pump was forwarded to the abbott zurich facility for further investigation.The investigation confirmed a damaged mosfet associated with one of the motor drive phases.A combination of internal hard and high-resistive short circuits in the mosfet driver resulted in increased power consumption.Consequently, the motor temperature and noise increased and the flow estimation became distorted.Because both drive phases are needed for motor start-up, the damaged mosfet resulted in the pump not restarting following the reported controller exchange.The root cause of the failure was determined to be the strong esd event, which the patient reportedly experienced immediately before the issue appeared in the log file data.The relevant sections of the device history records were reviewed and showed no deviations from mfg or qa specifications.Heartmate 3 lvas ifu contains information on all system controller alarms and how to resolve them.The static electric discharge section states that patients should be using battery power when performing activities that can generate static electricity, such as folding or changing bedsheets, taking laundry out of the dryer, dragging feet on a carpet, and touching the screens of older tvs or computers.The patient should be advised to reduce static electricity with products, such as a humidifier to add moisture to the air, dryer sheets and fabric softeners in clothes and bedsheets, anti-static spray on carpets and other materials, skin moisturizer, and cotton clothing and bedsheets.Static electricity is more common when the air is dry.Cold weather and home heating systems can make the air drier.A humidifier can make air less dry and reduce static electricity.Fabrics like wool, silk, and synthetic materials can build up static electricity.Patients should use cotton fabrics where possible.Additionally, the safety testing and classification tables in this ifu include electrostatic discharge information.Heartmate 3 lvas patient handbook warns that high levels of static electricity may damage or harm the system and may cause the pump to stop.The static electricity section states that when not sleeping or resting, you should use battery power instead of the mobile power unit to power the system.Using battery power can reduce the risk of system damage from high levels of static electricity.Static electricity occurs when two objects come into contact.You can receive a static shock when doing things such as folding or changing bedsheets, taking laundry out of the dryer, dragging feet on a carpet, and touching the screens of older tvs or computers.Fabrics loke wool, silk, and synthetic materials can build up static electricity.Use cotton fabrics when possible.Static electricity is more common when the air is dry.Cold weather and home heating system make the air drier.A humidifier can make air less dry and reduce static electricity.The what you should do subsection also recommends using products such as dryer sheets and fabric softeners, anti-static spray on carpets and other materials, skin moisturizer, and cotton fabric and bedsheets.Additionally, the safety testing and classification tables in section 9 include electrostatic discharge.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: 13474892
• MDR Text Key: 287695774
• Report Number: 2916596-2022-00434
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/04/2022
• Device Model Number: 106524INT
• Device Lot Number: 7651639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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?: Yes
• Date Device Manufactured: 09/04/2020
• 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): Hospitalization; Required Intervention
• Patient Sex: Male