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 Pleural Effusion (2010); Vomiting (2144); Ascites (2596); Renal Impairment (4499)

Event Date 05/08/2021

Event Type  Death  

Event Description

It was reported that the patient passed away on (b)(6) 2021 due to a failure to thrive.Additional details leading up to the patient's death were determined to be intermacs (interagency registry for mechanically assisted circulatory support) 1, intermittent dialysis, pleural effusions, ascites requiring multiple thoracentesis, poor intake which required a peg (percutaneous endoscopic gastrostomy) tube placement.The patient redeveloped ascites, 6 l removed.The patient also vomited during physical therapy with decreased levels of consciousness.The patient wished to go home and the family decided on hospice.The patient passed away shortly after.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct relationship between heartmate 3 left ventricular assist system (lvas), serial number (b)(4), and the reported events and patient outcome could not be conclusively determined through this evaluation.The device was not explanted 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 heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.This ifu lists renal dysfunction and death as adverse events that may be associated with the use of 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 (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: 15065587
• MDR Text Key: 296230952
• Report Number: 2916596-2022-12281
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/08/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7675311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2020
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White