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)

Patient Problems Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 03/01/2024

Event Type  Injury  

Manufacturer Narrative

Section a: patient weight and gender were not provided, request for this information has been made.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Event Description

It was reported that a patient who was implanted on (b)(6) 2024 had a low-speed advisory on (b)(6) 2024, which was the date they were taken back to the operating room for urgent right ventricular assist device (rvad) removal.Log file review was requested, and it was confirmed that the low-speed advisory on (b)(6) 2024 was due to the set speed being briefly set below the low-speed limit.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported right heart failure (rhf) could not be conclusively established through this evaluation.The controller event log file contained events from (b)(6) 2024.No notable events or alarms were captured, and the pump appeared to function as intended at the fixed speed.Multiple attempts were made to obtain additional information regarding the reported events; however, no further information was provided by the account.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).No further related events 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 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 the ifu, ¿introduction¿, lists adverse events, including right heart failure, that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 of the ifu (under "right heart failure") discusses the potential development of right heart failure following implant and outlines the associated treatment options, including inotropes and right ventricular assist device (rvad) placement.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: 18980862
• MDR Text Key: 338627002
• Report Number: 2916596-2024-01518
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

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: 106524US
• Device Lot Number: 10143309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2024
• 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): Required Intervention; Other
• Patient Age: 27 YR