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 Cardiomyopathy (1764); Death (1802); Liver Damage/Dysfunction (1954); Renal Failure (2041); Heart Failure (2206)

Event Date 12/03/2020

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 expired on (b)(6) 2020 due to end stage heart failure secondary to non-ischemic cardiomyopathy contributed by acute chronic renal and liver failure.No further information provided by hospital.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported end stage heart failure, renal dysfunction, hepatic dysfunction and subsequent patient outcome, as well as a direct correlation with the device, could not be determined through this evaluation.The account reported on (b)(6) 2020, that the patient expired due to end stage heart failure and non-ischemic cardiomyopathy contributed by acute chronic renal and liver failure.No additional information was provided by the account.The device was not returned for evaluation.The heartmate 3 instructions for use lists death, renal dysfunction, and hepatic dysfunction as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.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: 11055960
• MDR Text Key: 223157586
• Report Number: 2916596-2020-06169
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2022
• Device Model Number: 106524INT
• Device Lot Number: 7336329
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death