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 Cardiac Arrest (1762); Coma (2417); Low Oxygen Saturation (2477); Respiratory Failure (2484); Ischemia Stroke (4418); Respiratory Arrest (4461)

Event Date 04/29/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported respiratory failure and hypotension could not be conclusively determined.In addition, a direct correlation between heartmate 3 left ventricular assist system (lvas) (b)(4) and the reported events could not be conclusively established.Evaluation of the submitted log files confirmed low flow events which the account attributed to low mean arterial pressures (maps).The controller event log file captured 29 low flow fault flags, resulting in 11 low flow hazard alarms on (b)(6) 2022.The majority of the observed low flow events also appeared to be associated with elevated pi values.No other atypical events were captured.Despite these events, the pump appeared to function as intended and operated at the set speed for the duration of the file.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas) (b)(4).No product is available for investigation.The relevant sections of the device history records for (b)(4) was reviewed and showed no deviations from manufacturing or quality assurance specifications.The mod cable shipped on 11-apr-2022.The current heartmate 3 (hm3) lvas instructions for use (ifu), document 100169835 rev.C, lists respiratory failure as an adverse event that may be associated with the use of the hm3 lvas.The system monitor section of the ifu describes the pump flow display and pulsatility index (4-12 through 4-16) and the hazard alarms (4-18 and 4-30).This document states that the low flow hazard alarm will be triggered when pump flow is less than 2.5lpm and explains that changes in patient conditions can result in low flow.The alarms and troubleshooting section describes the actions to take in the event of a low flow alarm (7-7 and 7-11).The heartmate 3 lvas patient handbook rev.D is also currently available.Section 5 of this handbook, entitled "alarms and troubleshooting," 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 had hypercapneic respiratory failure with carbon dioxide (co2) in the 80s and there was a low flow alarm followed with loss of pulsatility on (b)(6) 2022.The patient was hospitalized at the time of the event.A review of the log files confirmed the low flow alarms with high pulsatility index (pi) readings that seemed to be physiological in nature.The cause of the respiratory failure was a collapsible trachea, and the patient received many sedatives for pain control.The respiratory failure was not device related.The cause of the low flow alarms was low mean arterial pressure (maps).The patient coded.Advanced cardiac life support (acls) was started and was intubated; return of spontaneous circulation (rosc) was achieved.The patient had not been arousable and had low oxygen saturations.On (b)(6) 2022, the patient received tracheostomy and percutaneous endoscopic gastrostomy (peg) and their neurologic status was guarded.The left ventricular assist device (lvad) functioned as intended, and there were no lvad related concerns.

• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 14488726
• MDR Text Key: 292512776
• Report Number: 2916596-2022-10785
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/13/2024
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8385759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• 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; Life Threatening
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American