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); Cardiogenic Shock (2262); Insufficient Information (4580)

Event Date 05/01/2020

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 passed away.The cause of death was pending.No autopsy was requested and the pump was not explanted.The pump would not be returned for evaluation.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported events (bleeding, cardiogenic shock) and subsequent patient outcome, as well as a direct correlation to heartmate 3 left ventricular assist system (lvas), serial number (b)(6) , could not be conclusively be determined through this evaluation.The heartmate 3 lvas instructions for use (ifu) lists bleeding and death as adverse events that may be associated with the use of the heartmate 3 lvas.The ifu also provides information regarding the recommended anticoagulation regimen and international normalized ratio values as well as suggested anticoagulation modifications in the event that there is a risk of bleeding.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specification.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the left ventricular assist device (lvad) was still implanted at time of death.The cause of death was cardiogenic shock and massive bleeding.The death was not considered device related.The device operated as expected.

• 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: 13121191
• MDR Text Key: 282994693
• Report Number: 2916596-2021-07287
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/30/2021
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6810472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2019
• 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 Sex: Male
• Patient Weight: 83 KG