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 Problems Cardiac Arrest (1762); Heart Failure/Congestive Heart Failure (4446)

Event Date 07/08/2022

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the patient had a cardiac arrest on (b)(6) 2022.Centrimag was placed for right side support.The patient was later taken back to the operating room (or) to explant the heartmate 3 (hm3) and convert them to extracorporeal membrane oxygenation (ecmo).Their care was withdrawn on (b)(6) 2022 and the patient passed away.

Event Description

It was reported that the patient had right ventricle failure leading up to cardiac arrest.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct relationship between the device and the reported cardiac arrest, right ventricle failure, and patient outcome could not be conclusively determined through this evaluation.(b)(6) was not returned for evaluation.Review of the device history records showed no deviations from manufacturing or qa (quality assurance) specifications.The heartmate 3 lvas instructions for use (ifu), is currently available.This ifu lists right heart failure and death as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.This document also discusses the potential development of right heart failure following implant and outlines the associated treatment options.Section 1 "introduction" explains that ventricular blood may flow either through the lvad or the aortic valve to reach the aorta, the proportion of which depends greatly upon the degree of the patient's cardiac function and the set speed of the lvad.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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15058977
• MDR Text Key: 296207320
• Report Number: 2916596-2022-12376
• 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: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/05/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8510125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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): Hospitalization; Required Intervention; Death
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American