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

Model Number 106524US

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

Patient Problems Renal Failure (2041); Septic Shock (2068)

Event Date 03/02/2022

Event Type  Death  

Manufacturer Narrative

(b)(4).Manufacturer's investigation conclusion: a direct relationship between the device and the reported renal dysfunction, multiorgan failure, sepsis, patient conditions (vasoplegia and hemodynamic compromise), and patient outcome could not be conclusively determined through this 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 heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) lists renal dysfunction, multiple organ failures/dysfunctions, and sepsis as adverse events that may be associated with the use of heartmate 3 lvas.Care instructions regarding preventing infection are provided in various sections of the ifu.The heartmate 3 lvas patient handbook provides care instructions regarding preventing infection.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient passed away due to renal failure and hemodynamic compromise.The hemodynamic compromise was a result of the patient's vasoplegia.Leading up to the patient's death they developed acute multisystem organ failure and had sepsis-related shock.The pump was not explanted and not returned for evaluation.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) 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: 13893002
• MDR Text Key: 287849741
• Report Number: 2916596-2022-01541
• 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
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/24/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8229071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: Black Or African American