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

Model Number 106524US

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intracranial Hemorrhage (1891); Fungal Infection (2419); Hemorrhagic Stroke (4417); Unspecified Mental, Emotional or Behavioural Problem (4430); Thrombosis/Thrombus (4440); Renal Impairment (4499)

Event Date 12/01/2023

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 the patient was admitted on (b)(6) 2023 for candida fungemia of unknown cause.They were treated with antifungals at home.The patient was in clinic having low flows on (b)(6) 2024.It was noted that there was recently diuresis and that they may be dry.Log files were submitted for review.The log file captured multiple low flow events on 14feb2024.The calculated flow appeared to have fluctuated below the alarm threshold of 2.5 lpm.It was noted that some of the low flow events were not sustained for long enough to activate the audible alarm and some of the low flow events occurred at times when the pulsatility index (pi) was elevated.The low flow events may have been a patient related issue and not an equipment related issue.The cause was identified to be hypovolemia and the low flow alarms improved with intravenous fluids.Their mean arterial pressure (map) was within the normal limit, and they had fatigue and loss of appetite that started on (b)(6) 2024.They were started on milrinone and sildenafil and continued fluconazole for their fungemia.Their blood culture on (b)(6) 2024 showed candida still growing so they were transitioned to intravenous micafungin.The patient was moved to the intensive care unit (icu) on (b)(6) 2024 due to suspicion of thrombus in inflow or outflow conduits of the left ventricular assist device (lvad); there was concern for obstruction at lvad outflow graft however the cause of the obstruction was unclear.On (b)(6) 2024, lvad speed was increased from 5600 rpm to 6000 rpm under echocardiogram by physician on the outflow graft to try to increase flows, but low flows still persisted.The patient's low flows had not improved so inotropes were started due to acute kidney injury (aki).On (b)(6) 2024, a computed tomography angiography (cta) followed by a transthoracic echocardiogram (tte) was done at bedside since flow was not seen through lvad with peak velocity through the inflow cannula was 3.7 m/s but there was no evidence of obstruction or thrombus/mass in the inflow cannula.No definite color flow seen with the outflow graft which was best visualized in the aortic arch.The tte with ramp was concerning for thrombus and inflow or outflow obstruction, and the cta demonstrated suspect of clot formation on inside of the outflow graft.Tissue plasminogen activator (tpa) x2 given on (b)(6) 2024 with increased flow on lvad subsequently up to 3.0lpm, which temporarily resolved low flow alarms.Follow-up log files were submitted for review.The log file was filled with low flow events.The pump files did show an increase in rotor noise and displacement.It was noted in the log file that when the set speed was briefly increased, the pump parameters changes as expected; that made it appear the pump was operating as intended but there appeared to be something interfering with the flow.The patient was stable in icu on dual inotropes.It was noted that the patient was not deemed a candidate for fibrinolytics or a surgical candidate for a device exchange due to fungemia ongoing.On (b)(6) 2024, the patient began having altered mental status (ams) without other focal deficits, urgent computed topography (ct) was performed with preliminary read of scattered subarachnoid hemorrhages.The patient became hypotensive on dobutamine, added on epinephrin and then levophed.Isosorbide increased respiratory distress and the patient was intubated by anesthesia and was started on fentanyl and propofol.The family was called to the patient's bedside and discussed patient case.Patient comfort care was placed, and the patient passed away on (b)(6) 2024.No autopsy was performed, and the device was not explanted.The outcome was deemed device related following low flows, suspected obstruction in the outflow graft, treatment with tpa, and subsequent stroke.

• 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: 18804113
• MDR Text Key: 336506179
• Report Number: 2916596-2024-01099
• Device Sequence Number: 1
• Product Code: DSQ
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• 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: 8943085
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2023
• 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): Death
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White