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

Model Number 106524US

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

Patient Problems Death (1802); Fall (1848); Hemorrhage/Bleeding (1888); Laceration(s) (1946); Blood Loss (2597)

Event Date 12/19/2020

Event Type  Death  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient fell and had multiple facial lacerations.The patient also had internal bleeding.The patient experienced continuous low flow alarms with low mean arterial pressures in the 30's upon emergency department arrival.The low flow alarms were noted and the controller showed the red heart illuminated with a continuous audible tone.The patient subsequently expired and no autopsy would be done.

Event Description

It was reported that the cause of death was internal bleeding.It was also noted that the cause of the low flow alarms was internal bleeding.The low flow alarms did not resolve before the patient's death.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported bleeding, as well as a direct correlation to heartmate 3 lvas, serial number (b)(6), could not conclusively be determined through this investigation.Although a specific cause for the reported low flow events could not conclusively be determine through this evaluation, the account communicated that they were due to bleeding.The relevant sections of the device history records for (b)(6), were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump was shipped on (b)(6) 2018.The current heartmate 3 lvas ifu lists bleeding and death as adverse events that may be associated with the use of heartmate 3 left ventricular assist system in section 1 ¿introduction¿.Section 6 ¿patient care and management¿ provides information regarding anticoagulation, including the recommended inr values.The heartmate 3 lvas ifu contains a section on ¿pump performance monitoring¿ under patient care and management which explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.Section 4.4 ¿clinical screen¿, contains sections on pump flow, pump speed, pulsatility index, and pump power.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.The heartmate 3 patient handbook contains a section on ¿alarms and troubleshooting¿ which provides information on all system alarms and the actions associated to resolve the alarms.A section on ¿handling emergencies¿ is also provided.The heartmate 3 instructions for use (ifu) list bleeding and death as adverse events that may be associated with the heartmate 3 left ventricular assist system.This ifu provides information regarding anticoagulation, including the recommended inr values.The heartmate 3 lvas ifu explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling and outlines all pump parameters.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.The heartmate 3 patient handbook states that in the event of a low flow hazard alarm, call the 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 (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11156815
• MDR Text Key: 226349394
• Report Number: 2916596-2020-06544
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/04/2021
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6612127
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Weight: 95