MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; Ventricular (assist) bypass

Model Number 106524US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 04/01/2024

Event Type  Death  

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 passed away after their left ventricular assist device (lvad) was turned off due to comfort care.Whether the outcome was device or therapy related was not provided.An autopsy was not performed.

Manufacturer Narrative

Manufacturer¿s investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas) serial number (b)(6), and the reported events and patient outcome could not be conclusively determined through this evaluation.An autopsy was not performed, and the pump was not explanted or returned.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 (hm) 3 left ventricular assist system (lvas) instructions for use (ifu) rev.C, lists the adverse events that may be associated with the use of the heartmate 3 left ventricular assist system, including death.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was additionally reported that on (b)(6) 2024, the patient developed chest pain and overall decline in condition.They presented to the local emergency department, decided on comfort measures, and were sent back to the long-term acute care hospital.The patient passed away on (b)(6) 2024 after their left ventricular assist device (lvad) was turned off due to comfort care.The outcome was not device or therapy related.The device operated as expected.

• 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: 19164734
• MDR Text Key: 340838511
• Report Number: 2916596-2024-02127
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: (01)00813024013297(10)8330745(17)231027
• 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
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/27/2023
• Device Model Number: 106524US
• Device Lot Number: 8330745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/08/2022
• 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): Death
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White