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 Low Blood Pressure/ Hypotension (1914); Heart Failure/Congestive Heart Failure (4446)

Event Date 07/08/2022

Event Type  Death  

Event Description

It was reported that the patient had low flow alarms on (b)(6) 2022 from 12:31-13:29 with complete loss of flow which prompted a system controller exchange.On (b)(6) 2022, the patient passed away due to right ventricular failure.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the log files provided by the account confirmed low flow alarms.Although a specific cause for these events could not be conclusively determined through this evaluation, the account reported that the alarms were caused by intraoperative hypotension and worsening right ventricular (rv) failure.A direct correlation between heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6), and the reported events and patient outcome could not be conclusively established.The controller event log file contained data from 30jun2022 through 08jul2022, per the timestamps.Low flow fault flags were captured on 08jul2022, when the estimated flow decreased below the low flow threshold of 2.5 liters per minute (lpm), to a range of 1.7-2.4 lpm.These faults resulted in 4 low flow hazard alarms, with the longest lasting over 57 minutes in duration.At 13:55:49 on 08jul2022, the driveline was disconnected from the system controller.This was followed by the disconnection of the black and white power cables and a controller shutdown sequence.These events were consistent with the reported controller exchange performed while the patient was in the or.The pump appeared to function as intended at the set speed while the driveline was connected to the system controller.It was also reported that heartmate 3 lvas, serial number (b)(6), would not be returned for evaluation.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 15mar2020.The heartmate 3 lvas instructions for use (ifu) and the heartmate 3 patient handbook are currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events, including right heart failure, that may be associated with the use of the heartmate 3 left ventricular assist system.Section 1 of the ifu also addresses all pump parameters, including pump flow.Section 4 of the ifu, ¿system monitor¿, describes the pump flow display and the hazard alarms.Per design, when the estimated flow value is calculated at less than 2.5 lpm, a low flow status is posted to the log file.If the flow remains below 2.5 lpm for 10 seconds, a low flow hazard alarm is triggered.Section 4 also explains that changes in patient condition can result in low flow.Section 6 of the ifu, ¿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.Additionally, section 6, under ¿caution!¿, 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 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.Furthermore, 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.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient was in the or for a non-device related cholecystectomy.No symptoms were observed, as the patient was under anesthesia at the time of the low flows.The alarms were reportedly due to the patient¿s intraoperative hypotension and worsening right ventricular (rv) failure; however, the alarms eventually resolved.The patient ultimately expired on (b)(6) 2022 due to the rv failure following the procedure.The patient outcome was not considered to be device related and the pump had operated as intended.

• 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: 15002485
• MDR Text Key: 295802233
• Report Number: 2916596-2022-12258
• 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: 07/28/2022

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 Expiration Date: 03/25/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7414226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 07/13/2022
• Supplement Dates Manufacturer Received: 07/28/2022
• Supplement Dates FDA Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2020
• 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): Death
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 155 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American