MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; Ventricular (assist) bypass

Model Number 106524INT

Device Problems Mechanical Problem (1384); Overheating of Device (1437); Decreased Pump Speed (1500); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Diarrhea (1811); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Discomfort (2330)

Event Date 04/09/2024

Event Type  Injury  

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 was admitted to the hospital due to general unwellness.A low blood pressure was detected and was taken care of clinically.Looking at the log file history, the power reading was noted to increase from the usual average of 5 watts to over 9 watts.The fixed speed was not able to be reached despite well filled left ventricle.The log files were downloaded and analyzed and high readings in power, rotor noise, and temperature were detected.The high power consumption was reported to be due to the imbalance of the rotor which caused the motor to work harder to maintain levitation.The scenario was said to has probably occurred due to an unstable rotor and some form of occlusion.The only confirmation for the occlusion were reported to be the readings of the pump parameters.The patient underwent an echocardiogram.However, the images could not be provided.Other than the low blood pressure the patient had slight nausea and loose stool.Their medication was adjusted to increase the blood pressure slightly.The patient was stable.

• 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: 19203446
• MDR Text Key: 341291194
• Report Number: 2916596-2024-02256
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011712
• UDI-Public: (01)00813024011712(10)7693449(17)220924
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/24/2022
• Device Model Number: 106524INT
• Device Lot Number: 7693449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/08/2020
• 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): Hospitalization; Required Intervention
• Patient Sex: Male