MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSISST) BYPASS

Catalog Number 106524

Device Problems Kinked (1339); Connection Problem (2900); Infusion or Flow Problem (2964)

Patient Problem Hemolysis (1886)

Event Date 05/02/2018

Event Type  Injury  

Manufacturer Narrative

The heartmate 3 lvas was implanted during the momentum 3 clinical trial, ide# (b)(4).Fda approval for heartmate 3 lvas was received on 23 august 2017.The same device is used commercially and in the ongoing momentum 3 trial.The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4).Age of device: 6 months and 7 days.The patient remains ongoing with the device.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017.It was reported that patient was brought to the emergency room (er) on (b)(6) 2018 due to low flow hazard alarm that lasted for 20 minutes.The patient was asymptomatic with the exception of elevated ldh of 614 u/l with a plasma free hemoglobin of 80 g/dl.Ct angiogram with 3d reconstruction revealed a filling defect in the outflow graft the patient underwent an outflow graft revision was performed on (b)(6) 2018.The outflow graft bend relief had become detached and caused kinking and compression of the outflow graft.The patient was stable post-procedure.No further information was provided.

Manufacturer Narrative

Investigation summary: the reported event of the bend relief disconnect and an outflow graft kink could not be confirmed through this evaluation.A direct correlation between heartmate 3 lvas, serial number (b)(4), and the reported events of elevated ldh and rv dysfunction could not be conclusively established through this investigation.Analysis of the submitted log files confirmed low flow alarms on 02may2018, 03may2018, 14may2018 and 15may2018; however, a specific cause for these events could not be determined through this evaluation.No other atypical events were captured and the pump operated at or above the low-speed limit throughout the duration of the log files.The pump appeared to operate as intended.The account reported that the patient was brought to the emergency room (er) on (b)(6) 2018 for a low flow alarm lasting approximately 20 minutes.The patient was essentially asymptomatic and lab results were unremarkable except for an increase in the patient¿s lactate dehydrogenase (ldh) level.The patient had a history of right ventricular (rv) dysfunction since the lvad implant on (b)(6) 2017 and had been on iv inotrope for right sided support; therefore, the low flow events were initially thought to be related to the rv dysfunction and patient¿s volume status.However, a computerized tomographic angiography (cta) with 3d reconstruction was done and noted a filling defect in the outflow graft, suggesting near occlusion of the outflow graft from a possible twist or thrombus.The patient was sent to the operating room (or) on (b)(6) 2018 for an outflow graft revision.During the operation, the surgeon noted that the outflow graft bend relief had detached and was causing injury to the outflow graft with kinking and compression.These issues were corrected and the patient was stable with consistent vad parameters.The hm3 lvas ifu lists hemolysis and right heart failure as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Information regarding the recommended anticoagulation therapy and inr range can also be found in this document.The ifu contains information on preparing the sealed outflow graft and instructs the user to verify that the graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief and ensuring that the line is straight.This document provides information regarding how to de-air the pump and confirm that the bend relief is fully connected and seated to the outflow graft, as well as, cautions the user to ensure that the sealed outflow graft bend relief remains connected during sternal closure.This ifu 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.This ifu also describes all system alarms and the recommended actions associated with them.The relevant sections of the device history records for (b)(4) (documents 193310, 192233, 189401, and 187033) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The relevant sections of the device history records for the percutaneous lead (documents 185390, 177656, and 176553) were also reviewed and showed no deviations from manufacturing or quality assurance specifications.No further information was provided.The patient remains ongoing on the device.The manufacturer is closing the file on this event.

Event Description

It was reported that right heart failure was not device related.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 7548777
• MDR Text Key: 109384288
• Report Number: 2916596-2018-02133
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 106524
• Device Lot Number: 6036878
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 43 YR
• Patient Weight: 115