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

Model Number 106524US

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

Patient Problem Stroke/CVA (1770)

Event Date 04/01/2024

Event Type  Injury  

Event Description

It was reported that the patient had a stroke on (b)(6) 2024.No further information was given.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported stroke could not be conclusively established through this evaluation.Additionally, the reported low flow alarms were confirmed through review of the submitted log files.A specific cause for the reported alarms could not be conclusively determined through this evaluation.Review of the submitted log files revealed multiple low flow alarms.The low flow events appeared to be associated with elevated pulsatility index values.These occurred while the pump was operating at a fixed speed of 4800 revolutions per minute (rpm), with a low speed limit (lsl) of 4600 rpm.The low flow events appeared to be associated with elevated pi values.Following a speed increase to 5000 rpm and then to 5200 rpm, no further low flow alarms occurred.The pump appeared to function as intended at the set speed.Multiple attempts for additional information were sent to the customer; however, no further information has been provided at this time.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).No product available 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 heartmate 3 left ventricle assist system (lvas) instructions for use (ifu) is currently available.Section 1, "introduction," lists stroke as a potential adverse event that may be associated with the use of heartmate 3 lvas.Section 4, ¿system monitor,¿ explains that the low flow hazard alarm occurs when pump flow is less than 2.5 liters per minute (lpm).A 10-second delay is imposed between the detection of the low flow status and the activation of the associated audio and visual indicators on the system controller.Changes in patient conditions can result in low flow.Section 6, ¿patient care and management¿ (under ¿anticoagulation¿), provides the recommended anticoagulation regimen, including international normalized ratio (inr) range, as well as suggested anticoagulation modifications.Section 7, ¿alarms and troubleshooting,¿ explains all system alarms and the recommended actions associated with them.The heartmate 3 lvas patient handbook also outlines all system controller alarms as well as how to respond to each alarm condition.No further information provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSIST) DEVICE
• 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: 19165133
• MDR Text Key: 340842894
• Report Number: 2916596-2024-02167
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: (01)00813024013297(10)10219688(17)251121
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 106524US
• Device Lot Number: 10219688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/22/2024
• 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): Other; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Ethnicity: Hispanic
• Patient Race: White