MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSIST) BYPASS

Model Number 106524

Device Problems Device Difficult to Setup or Prepare (1487); Pumping Stopped (1503)

Patient Problem Cardiac Arrest (1762)

Event Date 03/26/2022

Event Type  Death  

Event Description

It was reported that the patient's wife heard the patient's device alarming in the early morning.She noted the driveline was disconnected from the controller.She tried to reconnect the driveline and struggled.Emergency medical services (ems) began cardiopulmonary resuscitation (cpr) but the patient was not able to be revived.The patient passed away due to cardiac arrest.Related manufacturer report number: 2916596-2022-12037.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of the driveline disconnect could not be confirmed as no log files were submitted for evaluation.A specific cause for the driveline disconnect could not be conclusively determined through this evaluation.The report of the driveline being difficult to reconnect could not be confirmed as no device was returned for evaluation.It was reported the outcome was device or therapy-related.No autopsy will be performed.The device was not explanted and will not be returned for evaluation.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 14sep2018.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.This ifu lists potential adverse events, including death, that may be associated with the use of the heartmate 3 left ventricular assist system.The ifu, "alarms and troubleshooting", and section 5 of the patient handbook, "alarms and troubleshooting", address all system alarm conditions as well as the appropriate actions associated with each condition.Furthermore, the patient handbook, ¿handling emergencies¿, also provides examples of emergencies and the proper actions to take in the event an emergency occurs.The heartmate 3 patient handbook, ¿how your heart pump works,¿ under sub-section titled "connecting the driveline to the system controller,") addresses the proper steps for connecting the driveline to the system controller.The heartmate 3 patient handbook section titled "emergency contact list") cautions users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• 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: 14875339
• MDR Text Key: 295045040
• Report Number: 2916596-2022-11834
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 813024013297
• 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
• Report Date: 06/30/2022

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: 05/24/2021
• Device Model Number: 106524
• Device Lot Number: 6626591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2018
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 84 KG