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

Model Number 106524US

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dehydration (1807); Low Blood Pressure/ Hypotension (1914); Heart Failure/Congestive Heart Failure (4446); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 06/10/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient heard an alarm and the message on the system controller stated the patient needed to go to the hospital.The patient was mildly hypotensive so metoprolol was discontinued and was started on midodrine for blood pressure support.On admission the patient was warm, had no acute pain, the driveline was intact, and was hemodynamically stable.Echocardiogram was done which showed septal bowing towards the left ventricle with severe right ventricular dilation and severe tricuspid regurgitation.The patient's lvad speed was lowered to 5000 but the patient's blood pressure did not tolerate this and lvad speed was reverted back to 5100 prior to discharge.There were no alarms on review and lvad parameters were stable.Upon interrogation the patient had 1 low flow at 12:30 pm on (b)(6) 2022.The patient has not been drinking enough water and has not been checking his weight.There were also several low flow flags that did not persist long enough to trigger a low flow alarm.The patient appeared to be euvolemic, torsemide was given at 20 mg daily with flex dosing of extra 20 mg as needed for weight gain of 2lbs in one day or 5lbs in one week.Ace/arb/arni was deferred secondary to hypotension.The patient's hypotension was treated with midodrine 10mg three times a day and the patient was to follow up with the hospital.The patient was evaluated by physical therapy and deemed safe to be discharged home.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the submitted log files confirmed a low flow hazard alarm.Although a specific cause for the low flow hazard alarm could not be conclusively determined, the account reported that the patient was hypotensive.A direct correlation between (b)(6) and the reported events could not be conclusively determined through this investigation.The submitted controller event log file captured a transient low flow hazard alarm on (b)(6) 2022.Of note, pulsatility index (pi) was elevated during the observed low flow event.No other notable events or alarms were captured.The system appeared to operate as intended at the set speed for the duration of the file.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number: (b)(6), and no further related events have been reported at this time.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviation from manufacturing or quality assurance specifications.The heartmate (hm) 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 of the ifu, ¿introduction¿, lists right heart failure as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.Section 5 of the ifu, ¿surgical procedures¿, warns that moderate to severe aortic insufficiency must be corrected at the time of device implant.If not addressed, the lvad will not be able to provide the intended flow.Section 6, ¿patient care and management¿ (under ¿right heart failure), states that patients may develop right ventricular failure during or shortly after implant and outlines the associated treatment options.Section 6 (under ¿caution!¿) further explains that 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 1 of this ifu also provides an explanation of all pump parameters, including flow.This section explains that pump flow is a calculated value that is estimated based on pump power.Section 4 ¿system monitor¿ provides information about the pump flow display and the low flow hazard alarm condition.This section states that the low flow hazard alarm will be triggered when the estimated pump flow is less than 2.5 lpm and explains that changes in patient conditions can result in low flow.Section 7 ¿alarms and troubleshooting¿ describes all alarm conditions, including the low flow hazard, as well as the appropriate actions associated with them.Heartmate 3 lvas patient handbook is currently available.Section 5 "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.This document instructs the user that in the event of a low flow hazard alarm, call your hospital contact immediately for diagnosis and instructions.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: 14886054
• MDR Text Key: 295125466
• Report Number: 2916596-2022-11887
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/27/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8288066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• 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; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American