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

Model Number 106524INT

Device Problem Infusion or Flow Problem (2964)

Patient Problem Right Ventricular Dysfunction (2054)

Event Date 10/13/2020

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 suffered from low flow alarms.Right ventricular (rv) function had been reduced since time of implant and could be related to the event although patient is clinically fine.Medical treatment was administered but no significant changes.The low flow alarms resolved after software upgrade.

Manufacturer Narrative

Section g3 and h4: correction.Manufacturer's investigation conclusion: a direct correlation between the report of reduced right ventricular (rv) function and heartmate 3 left ventricular assist system (lvas), serial number (b)(6), could not be conclusively determined through this investigation.The reported low flow alarms were confirmed by an onsite abbott representative who successfully performed a low flow software upgrade on (b)(6) 2020.The low flow alarms reportedly resolved following the upgrade.The patient remains ongoing on heartmate 3 left ventricular assist system serial number (b)(6), and no further related issues 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 heartmate 3 (hm3) left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 of this document lists right heart failure as a possible adverse event associated with the use of the hm3 lvas.Section 4 of this document describes that low flow alarms occur when the estimated flow decreases below 2.5 lpm.This section also explains that changes in patient condition can cause low flow, such as hypertension.Section 6 of the ifu explains patient care and management, including how to address right heart failure, as well as typical treatment options.Section 7 of the ifu explains all alarms, including low flow, and provides instruction for patient care following an alarm.The alarms and troubleshooting section of the hm3 patient handbook explains how the low flow hazard alarm presents on the system controller and what actions should be taken to resolve the alarm.A section on handling emergencies is also provided in this document.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 (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10718074
• MDR Text Key: 212489535
• Report Number: 2916596-2020-05230
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2021
• Device Model Number: 106524INT
• Device Lot Number: 6535999
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention