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

Model Number 106524INT

Device Problems Malposition of Device (2616); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that for the bi-ventricular assist device (bivad) patient the right vad (rvad) outflow cannula was believed to be obstructed/compressed as it passes by the housing of the left vad (lvad) pump.There were increasing low flow alarms with elevated pulsatility index (pi) on the rvad on (b)(6) 2020, which were seen again in (b)(6).A power injection of contrast into the right atrium was performed and no contrast could be seen going through the rvad but it seemed to go through the right ventricle.It is believed that the rvad sits in an unusual position since the initial implant and that this has been exaggerated over time.

Manufacturer Narrative

Manufacturer's investigation conclusion: the evaluation of the submitted log files confirmed low flow events; however, the report of malpositioning of the patient¿s right ventricular assist device (rvad) and obstruction of the outflow graft on the patient¿s rvad could not be confirmed as no images or scans were provided for evaluation.The controller event log files contained data from (b)(6) 2020.Pump speed was stable for the duration of the log files.The log file recorded several, transient low flow alarms when the flow decreased below the low flow threshold of 2.5 lpm for 10 seconds or longer.The low flow alarms resolved when the patient¿s flow increased above the low flow threshold of 2.5 lpm.The controller periodic log files captured low flow alarms on (b)(6) 2020.Of note, a gradual decrease in flow was observed throughout the periodic files.The pump appeared to be operating as intended.The account reported that the patient was experiencing increased low flow alarms on their rvad.The account reported that the patient¿s rvad was suspected to be sitting in an unusual position since implant that became exaggerated over the duration of patient support.The account also suspected that the patient¿s rvad outflow cannula was obstructed.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) explains how to insert the pump in the ventricle and instructs the user to take care to avoid orienting the inlet towards the interventricular septum.Pump function will be compromised in the presence of inlet obstruction.This document also outlines the steps to reorient the pump.In addition, this ifu explains that the low flow hazard alarm is triggered when pump flow is less than 2.5 lpm, the pump has stopped, the pump is not operating properly, or the driveline is disconnected from the system controller.This ifu and the heartmate 3 lvas patient handbook explain all system alarms and the recommended actions associated with them.The heartmate 3 lvas ifu also provides instructions regarding the preparation, installation, and orientation of the sealed outflow graft.The ifu 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 also cautions the user that the sealed outflow graft must not be kinked or positioned where it could abrade against a pump component, surgical element, or body structure.Review of the device history records showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped to the customer on 20mar2017.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10641103
• MDR Text Key: 210160876
• Report Number: 2916596-2020-04614
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 106524INT
• Device Lot Number: 5911074
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization