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

Model Number 106524US

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

Patient Problems Arrhythmia (1721); Hematoma (1884); Myocardial Infarction (1969); Pleural Effusion (2010); Brain Injury (2219); Heart Failure/Congestive Heart Failure (4446); Renal Impairment (4499)

Event Date 11/20/2021

Event Type  Death  

Event Description

It was reported that the patient had a large hematoma around the outflow graft in the anterior mediastinum and a moderate-sized right pleural effusion on (b)(6) 2021.These were seen on a computerized tomography (ct) chest scan on (b)(6) 2021.The patient was hospitalized where they received 1 unit of platelets.Additional information revealed that the patient was treated using continuous renal replacement therapy (crrt) for acute kidney injury (aki) and volume overload.The patient has intubated on (b)(6) 2021 at 0013.While in the operating room (or), they had intermittent cardiopulmonary resuscitation (cpr) due to low flow alarms and the inability of their left ventricular assist device to support him.The patient also received defibrillation for supraventricular tachycardia (svt).The patient had a right ventricular assist device (rvad) placed to help the patient come off bypass after having arrived at the emergency room (er) with left-sided chest pain.On (b)(6) 2021 at 2032 the patient's troponin was 215 on (b)(6) 2021 at 1510 creatine kinase (ck) levels were at 702.The patient had hepatic dysfunction.There was also reported neurological dysfunction in the form of anoxic brain injury.An electroencephalogram was requested and revealed slowed waveforms consistent with anoxic brain injury.The patient expired on (b)(6) 2021.The patient had a myocardial infarction.Additionally, the patient's cause of death was determined to be brain death due to hemorrhagic shock.The patient had a clinic visit on (b)(6) 2021 and had an unremarkable follow-up visit prior to the event.

Manufacturer Narrative

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

Manufacturer Narrative

Section d6b: explant date was inadvertently added in initial report.The patient's pump was not explanted after death.Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas, serial number (b)(6), and the reported events and subsequent patient outcome could not be conclusively established through this evaluation.No autopsy was performed; therefore, no product is available for investigation.The relevant sections of the device history records for (b)(6) was reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump shipped on 22feb2021.The heartmate 3 lvas ifu, rev.C, lists bleeding, cardiac arrhythmia, various forms of organ failure, myocardial infarction, and death as an adverse event that may be associated with the use of heartmate 3 lvas.This document also provides information regarding anticoagulation, including recommended inr values, and the suggested anticoagulation modifications in the event that there is a risk of bleeding.The system monitor section of the ifu describes the pump flow display and pulsatility index (4-12 through 4-16) and the hazard alarms (4-18 and 4-30).This document states that the low flow hazard alarm will be triggered when pump flow is less than 2.5lpm and explains that changes in patient conditions can result in low flow.The alarms and troubleshooting section describes the actions to take in the event of a low flow alarm (7-7 and 7-11).The heartmate 3 lvas patient handbook, rev.D, is also currently available.Section 5 of this handbook, entitled "alarms and troubleshooting," describes the actions to take in the event of a low flow alarm.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information revealed elevated international normalized ratio (inr) with rapid onset.On (b)(6) 2021, inr was 2.0, on (b)(6) 2021, inr was 2.4, on (b)(6) 2021, inr was 4.5, and , on (b)(6) 2021, inr was 3.6.No occlusion was noted intraoperatively on (b)(6) 2021.The graft was found to have pulled away from aortic tissue at the anastomosis.The cause of low flow alarms is presumed to be low blood volume.The pump was returned.No postmortem explant was performed.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 13011414
• MDR Text Key: 282281868
• Report Number: 2916596-2021-07201
• 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: Study,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/25/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7809995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 02/18/2022
• Supplement Dates FDA Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2021
• 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): Life Threatening; Death; Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White