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 Death (1802); Heart Failure/Congestive Heart Failure (4446)

Event Date 12/01/2020

Event Type  Death  

Manufacturer Narrative

The event date has been estimated.

Event Description

It was reported that the patient was placed in hospice care in (b)(6) 2020 following issues with right heart failure.The right ventricular dysfunction started on (b)(6) 2021 and the percutaneous rvad was inserted on (b)(6) 2021.The patient had a coronary artery intervention with dye.After the procedure the patient had to be placed on cardiac resynchronization therapy (crt) due to the dye affecting the patient's kidneys.It was also believed that the patient got crt due to constant ventricular tachycardia episodes and right ventricular failure the patient was then trached and vented.The patient required rvad support and once it was discontinued the patient declined requiring hospice care.The family withdrew treatment on (b)(6) 2021.The pump will not be returned and there will not be an autopsy.The death was not considered to be device related and the device operated as expected.

Event Description

It was reported that the percutaneous right ventricular assist device (rvad) cannula via right internal jugular vein (protek duo 31f veno-venous dual lumen cannula) was inserted under fluoroscopic guidance on (b)(6) 2021.A veno-venous (v-v) ecmo for right-side of heart was inserted and the right femoral venous quinton catheter for continuous renal replacement therapy (crrt) was inserted.

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, cardiac arrhythmia, and renal dysfunction could not be conclusively determined through this evaluation.The heartmate 3 lvas instructions for use (ifu) lists right heart failure and cardiac arrhythmia as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.This document also lists arrhythmia as a potential late postimplant complication.The relevant sections of the device history records for (b)(6), 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: 11373046
• MDR Text Key: 233302230
• Report Number: 2916596-2021-00695
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

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: Lay User/Patient
• Device Expiration Date: 08/28/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7582681
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Weight: 67