MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); Ventricular (assist) bypass

Model Number 104911

Device Problems Mechanical Problem (1384); Decreased Pump Speed (1500); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypervolemia (2664); Multiple Organ Failure (3261); Thrombosis/Thrombus (4440)

Event Date 03/13/2024

Event Type  Injury  

Event Description

It was reported that the patient was seen in clinic and was noted to have a low speed advisory at 7800 on (b)(6) 2024.The patient reported "+++" readings and audible alarm when changing positions at home.Flows were noted to be 8-9 l in clinic with the patient having clinical symptoms of hypervolemia and end organ dysfunction.Log files were submitted to review flow trends for any signs of pump thrombosis and possible concerns of percutaneous lead malfunction.The log file contained approximately 14 days of data and the set speed was at9200rpm.The average power ranged from 6.5watts to 14.5 watts, the average pulsatility index (pi) ranged from 2.8 to 4.2, and the average flow ranged from 6lpm to 10.4lpm.The log file captured 16power elevations above 10watts and one low speed advisory event was seen while connected to battery power that self resolved quickly.There was insufficient evidence to determine the exact cause of the event.X-rays were also submitted that showed an area of concern about 2 inches from the clamshell repair.Additional log files were submitted for review that contained no unusual events.It was also confirmed that there has been no further issues since the low speed advisory event.

Manufacturer Narrative

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

• 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: 19015169
• MDR Text Key: 339082129
• Report Number: 2916596-2024-01660
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011170
• UDI-Public: (01)00813024011170(10)
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date: 04/01/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 104911
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 103 KG