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 Problem Stroke/CVA (1770)

Event Date 09/01/2023

Event Type  Death  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Event Description

It was reported that the patient passed away due to a failure to thrive.The patient experienced stroke like symptoms approximately postoperative delirium (pod) on (b)(6) 2023.As a result of this the patient had a complicated post operative course that limited their ability to rehabilitate physically.As such, the patient was unable to reach good quality of life and was eventually considered failure to thrive.A family meeting led to the decision to withdraw care which eventually occurred on (b)(6) 2023, and the patient passed away shortly thereafter.The outcome was not device or therapy related; the device operated as intended.The device was not explanted.

Manufacturer Narrative

A direct correlation between heartrate 3 left ventricular assist system (lvas), serial number mlp-(b)(6) and the patient¿s outcome could not be conclusively established through this evaluation.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The relevant sections of the device history records for mlp-(b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartrate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1, ¿introduction¿, lists potential adverse events that may be associated with the use of the heartmate 3 lvas, including other neurological events (not stroke-related), stroke, and death.Section 6 of the ifu, ¿patient care and management¿ provides information regarding anticoagulation, including the recommended inr (international normalized ratio) values.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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 19162791
• MDR Text Key: 340803200
• Report Number: 2916596-2024-02299
• 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,Followup
• Report Date: 04/30/2024

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 Model Number: 106524US
• Device Lot Number: 9079692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/05/2023
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White