MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSIST) BYPASS

Model Number 106015

Device Problems Mechanical Problem (1384); Pumping Stopped (1503); No Apparent Adverse Event (3189)

Patient Problems Chest Pain (1776); Dyspnea (1816); Hemolysis (1886); Hematuria (2558); Thrombosis/Thrombus (4440)

Event Date 02/29/2024

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 presented to the emergency department (ed) via emergency medical services (ems) for chest pain and shortness of breath.The patients lactate dehydrogenase (ldh) was 1627 and urinalysis with a large amount of blood revealed that the urine red blood cell (rbc) count of 11-20.Log files were submitted for review and captured pulsatility index (pi) events throughout log file history.The log files also captured elevated pump power and flow on (b)(6) 2024.The patient was too unstable for a computed tomography (ct) scan to be performed due to multiple pump stops, there was no obvious thrombus seen on the echocardiogram.The cause of the elevated labs, hematuria and elevated power and flow was thought to be thrombus/hemolysis.The patient was made comfort care, the system controller was disconnected on (b)(6) 2024, and the patient expired on (b)(6) 2024.The cause of the pump stops was undetermined; however, it was noted that patient had phase to phase driveline issues that caused pump stops in the past.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• 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: 18952982
• MDR Text Key: 338272715
• Report Number: 2916596-2024-01409
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 106015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 127 KG