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

Model Number 106524US

Device Problems Decreased Pump Speed (1500); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Gastrointestinal Hemorrhage (4476)

Event Date 12/13/2023

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the patient was seen in the emergency room for a gastrointestinal bleed.Their speed was decreased from 5600 revolutions per minute (rpm) to 5100 rpm.Log files were submitted for review.The log file captured constant pulsatility index events throughout the log file which shortened the data capture to only a few hours.

Event Description

The patient passed away on (b)(6) 2023.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6), and the reported gastrointestinal (gi) bleeding and patient outcome could not be conclusively determined through this evaluation.Review of the submitted log files revealed the device operating as expected.Of note, there were numerous pulsatility index (pi) events that filled the majority of the controller event log file and would have overwritten older data, per design.No notable events or alarms were captured.It was later reported that the patient expired on (b)(6) 2023.Multiple attempts for additional information were sent to the customer; however, no further information has been provided at this time.No product was returned for investigation.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 left ventricular assist system (lvas) instructions for use (ifu), rev.C, and the heartmate 3 patient handbook, rev.D, are currently available.Section 1 of this document lists adverse events, including bleeding and death, that may be associated with the use of the heartmate 3 left ventricular assist system.Section 4 explains that pi events are assumed by the system during cases when there are sudden and substantial changes in the pulsatility index.These events are also referred to as pi events, and may be initiated for reasons other than true pi events.Some reasons include sudden changes in a patient¿s volume status, arrhythmias, sudden changes in power, and sudden changes in pump speed.Section 6, ¿patient care and management¿ (under ¿anticoagulation¿), also provides the recommended anticoagulation regimen, including international normalized ratio (inr) range, as well as suggested anticoagulation modifications.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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18389028
• MDR Text Key: 331283294
• Report Number: 2916596-2023-08718
• 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: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/11/2022
• Device Model Number: 106524US
• Device Lot Number: 7841136
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 01/10/2024; 02/22/2024
• Supplement Dates FDA Received: 02/01/2024; 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2021
• 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): Hospitalization; Life Threatening; Death
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 73 KG