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 Hemorrhage/Bleeding (1888); Septic Shock (2068); Bowel Perforation (2668); Thrombosis/Thrombus (4440); Liver Failure (4492)

Event Date 03/21/2021

Event Type  Death  

Event Description

It was reported that the patient passed away.The patient had a multi organ failure, including disseminated intravascular coagulation, acute hepatic failure, covid-19, a bowel perforation, septic, and hemorrhagic shock.It was reported that the patient's outcome was not device related and pump operated as expected.The device will not be returned for evaluation.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system, serial number: (b)(6), and the reported events (patient expiration, multisystem organ failure, hepatic dysfunction, sepsis, and patient condition) could not be conclusively determined through this investigation.The heartmate 3 left ventricular assist system instructions for use, rev.C, contains the following information: section 1 lists sepsis, death, and hepatic dysfunction as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.Section 6 provides information regarding anticoagulation.Care instructions regarding preventing infection are provided in various sections of this document.The relevant sections of the device history records were reviewed and showed no deviation from manufacturing or quality assurance specifications.The implant kit shipped on 02jun2019.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: 11657437
• MDR Text Key: 245158330
• Report Number: 2916596-2021-01776
• 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: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/26/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6996660
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 63 YR
• Patient Weight: 117