MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

Model Number 106524INT

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

Patient Problems Death (1802); Right Ventricular Failure (2055); Multiple Organ Failure (3261)

Event Date 08/24/2019

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 due to multi-system organ failure and right heart failure.It was reported that the patient's follow-up occurred in an external hospital.The patient developed a progressive mof (multiple organ failure) and subsequently a rhf (right heart failure), which was not treatable at the end.According to the clinic, mof was related to the outcome at least.Privacy laws prohibit the customer from providing information regarding the case.No autopsy was performed.The device was not explanted.The device will not be returned for evaluation.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct relationship between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported right heart failure, multi-system organ failure, and patient outcome could not be conclusively determined through this evaluation.The account reported that the patient expired on (b)(6) 2019, due to multi-system organ failure and right heart failure.No autopsy was performed, and the device was not returned for evaluation.Privacy laws prohibit the customer from providing information regarding the case.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) lists right heart failure and multiple organ dysfunctions/failures as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.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 (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11099022
• MDR Text Key: 224510639
• Report Number: 2916596-2020-06569
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/17/2021
• Device Model Number: 106524INT
• Device Lot Number: 6705401
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death