MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSIST) BYPASS

Model Number 106524INT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); Ischemia (1942); Thromboembolism (2654); Thrombosis/Thrombus (4440)

Event Date 12/02/2023

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the patient had a small bowel obstruction and went to the operating room (or) where they had jejunum resected and a primary distal jejunum to duodenum anastomosis.The gut was rested for one week but the patient continued to have low hemoglobin requiring regular blood transfusions.Computed tomography (ct) and gastroscopy was performed on (b)(6) 2023 for suspected bleeding and bowel obstruction.On (b)(6) 2023, the patient was taken back to the or for a relook laparotomy.Upon returning from the or, in the cardiovascular intensive care unit (cvicu), the patient had blown pupil and head ct was performed that showed a massive intercranial bleed.Care was withdrawn on (b)(6) 2023 and the patient passed away.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas (left ventricular assist system), serial number (b)(6), and the patient's outcome could not conclusively be determined through this evaluation.Heartmate 3 lvas, serial number (b)(6), was reported to have been operating as intended at the time of the patient's outcome.It was also reported that the device will not be returned for evaluation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviation from manufacturing or quality assurance specifications.The current heartmate 3 left ventricular assist system instructions for use (ifu) contains the following information: section 1 outlines potential adverse events, including thromboembolism, bleeding, stroke, and death that may be associated with the use of heartmate 3 left ventricular assist system.Section 6 lists thromboembolism as a late post-implant complication that may be associated with the use of the heartmate 3 left ventricular assist system.Information regarding recommended anticoagulation therapy and international normalized ratio range is also provided in this section.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information was received that the patient developed clinical and radiographic evidence of mesenteric ischemia and proceeded to laparotomy where one meter segment of jejunum was resected.This was likely secondary to embolism from the aortic root clot which was being managed with therapeutic anticoagulation.The death certificate was issued with an information that stated intracranial hemorrhage and lymphocytic myocarditis requiring implantation in the left ventricular assist device.The device reportedly operated as expected.

• 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: 18410176
• MDR Text Key: 331513947
• Report Number: 2916596-2023-08767
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 106524INT
• Device Lot Number: 8659053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2022
• 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: 34 YR
• Patient Sex: Female
• Patient Weight: 68 KG