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

Model Number 106524US

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Dizziness (2194); Presyncope (4410)

Event Date 02/18/2024

Event Type  Injury  

Event Description

It was reported that around 9:15am the patient developed low flow alarms with flows of 0.3 lpm after sitting in a chair for more than 3 hours.They experienced a headache, lightheadedness, and dizziness.The patient's mean arterial pressure (map) was in the 60s and their heart rate was 100.The decision was made to do a system controller exchange.The patient switched to their secondary controller.The secondary controller "did not work" and the pump did not turn on.No left ventricular assist device (lvad) hum was heard on chest.The patient's map dropped to the 50s.They remained awake and alert.The patient reported they felt lightheaded, dizzy, and developed a headache.The patient switched back to their primary controller.With epinephrine and albumin started, the patient's flows returned to 3-5 lpm.They patient was now hemodynamically stable with stable pump parameters with epinephrine off.At bedside the driveline was intact, the modular cable connection was tight, the power cables were intact, and the batteries were charged.Log files contained the onset of low flow hazard events on (b)(6) 2024 between 9:16am - 9:19am just before the driveline was disconnected from the controller.During the event the log recorded a slightly increased motor power with low flow hazard alarms and internal motor instability faults.Log files from the secondary controller did not appear to contain any pump connection.The pump appeared to resume operation once reconnected to the primary controller on (b)(6) 2023 at 9:21am.System controller mfr # 2916596-2024-01143.

Manufacturer Narrative

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

• 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: 18861385
• MDR Text Key: 337184887
• Report Number: 2916596-2024-01196
• 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
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106524US
• Device Lot Number: 10155191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2024
• 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): Required Intervention; Hospitalization
• Patient Sex: Male