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

Model Number 106524INT

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

Patient Problem Insufficient Information (4580)

Event Date 04/03/2024

Event Type  Death  

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported patient outcome could not be conclusively determined through this evaluation.It was communicated that due to patient privacy laws, the managing hospital will not communicate any further patient outcome information.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 lvas instructions for use (ifu), is currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events, including death, that may be associated with the use of the heartmate 3 left ventricular assist system.No further information was provided.The manufacturer's investigation completion.

Event Description

It was reported that the patient passed away on (b)(6) 2024.The cause was not provided; however, the outcome was not device or therapy related.

• 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: 19159432
• MDR Text Key: 340770021
• Report Number: 2916596-2024-02335
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011712
• UDI-Public: (01)00813024011712(10)9005528(17)240908
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2024

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 106524INT
• Device Lot Number: 9005528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/21/2023
• 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