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

Model Number 106524US

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

Patient Problems Stroke/CVA (1770); Coagulation Disorder (1779); Hemorrhage/Bleeding (1888); Respiratory Failure (2484); Ischemia Stroke (4418); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 12/19/2023

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 event log files were submitted for review on a patient on a newly implanted patient with flows of 1.3 liters per minute (lpm) in the operating room (or).The event log files captured persistent low flow events as well as sustained low flow hazard events as well as low speed advisory events which were associated with pump speed being set below the low speed limit.The events resolved when these speed settings were appropriately set.There were no rotor faults or any abnormal pump faults.Additional information was provided that the low flow events were caused by blood loss.Diagnostic testing including a transesophageal echocardiography (tee), laboratory values, and a computed tomography (ct) were performed.Drops in the patient's hemoglobin and hematocrit were seen as well as increased chest tube drainage which confirmed bleeding.The source of the bleeding was unknown.The patient's flow remained below 2.5 lpm, so a low flow alarm threshold adjustment to 2.0 lpm was performed.The patient returned to the or that evening for exploration and to repack the open chest.They also received multiple blood products and the bleeding was reported as resolved.The patient was critical but stable and had a flow of 2.0 to 2.1 lpm.There were no rotor faults or any abnormal pump faults.

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 later passed away due to cardiopulmonary failure.The patient had a cerebral vascular accident (cva).The cause of death was a simultaneous bleeding and hypercoagulable state that was not controlled despite medical efforts.The outcome was not device related.The device operated as expected.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the submitted log files confirmed low flow alarms.Although a specific cause for the low flow events could not be conclusively determined through this evaluation, the account later communicated that they were associated with bleeding.A direct correlation between the device and the reported events and patient outcome could not be conclusively established through this evaluation.The submitted system controller event log file captured a continuous low flow alarm on the day of implant ((b)(6) 2023).No other notable alarms or events were captured.The pump operated as intended at the set speed.It was communicated that an autopsy was not performed, and the device was not explanted for evaluation.The heartmate 3 left ventricle assist system (lvas) instructions for use (ifu), rev.C is currently available.Section 1, "introduction", lists bleeding, stroke, venous thromboembolism, arterial non-central nervous system (cns) thromboembolism, and death as potential adverse events which may be associated with the use of heartmate 3 lvas.This section also outlines pump parameters, including pump flow.Section 4, ¿system monitor¿, explains that the low flow hazard alarm occurs when pump flow is less than 2.5 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 also 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 system alarms and the recommended actions associated with them.The heartmate 3 lvas patient handbook, rev.D is also currently available.Section 5, "alarms and troubleshooting", also outlines system controller alarms as well as how to respond to each alarm condition.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient had an ischemic stroke.A non-contrast computerized tomography (nchct) captured subacute infarctions of the cerebellum.A computed tomography perfusion (ctp) captured an increased time to maximum of the tissue residue function (tmax) in the inferior left cerebellar hemisphere and superior medial right cerebellar hemisphere, decreased cerebral blood volume in the medial right cerebellar hemisphere which was compatible with core infarction.The area of increased tmax in the inferior left cerebellum also corresponded to core infarction.A head and neck computed tomography angiography (cta) was performed and captured occlusion on the left posterior inferior cerebellar artery (pica), moderate narrowing of the left cervical inferior cerebellar artery (ica), and thrombus adherent to the aortic valve.

• 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: 18428556
• MDR Text Key: 331797287
• Report Number: 2916596-2023-08844
• 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,Followup,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• 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: 10045613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2023
• 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; Life Threatening; Death; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American