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

Model Number 106524US

Device Problems Failure to Align (2522); Malposition of Device (2616); Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2021

Event Type  malfunction  

Event Description

It was reported that the patient's log file captured low flow events on (b)(6) 2021.The low flow events occurred at times when the pulsatility index (pi) was elevated.The cause of the low flow alarms was determined to be cannula malposition.The patient was stable and a right heart catheterization with ramp was done on (b)(6) 2021.The pump speed was lowered and the low flow alarms decreased.The patient was discharged.

Manufacturer Narrative

Manufacturer's investigation conclusion: the evaluation of the submitted log files confirmed the reported low flow alarms, and the account reported that the cause of the alarms was cannula malposition.A direct correlation between the device and the reported inflow conduit misalignment could not conclusively be established through this investigation.The controller event log file contained data from (b)(6) 2021 09:26:10 through (b)(6) 2021 10:20:56.Transient low flow fault flags were captured throughout the duration of the file, resulting in a total of 31 low flow hazard alarms on (b)(6) 2021.No other atypical events were captured.Despite these alarms, the pump appeared to function as intended and operated at the set speed for the duration of the file.The controller periodic and lvad event and periodic log files captured low flow events.The account communicated that the cause of the low flow alarms was likely cannula malposition.The patient was stable.A right heart catheterization (rhc) with ramp was planned; however, the account ended up decreasing the speed, which decreased the low flow alarms.Cannula malposition was confirmed and documented in the discharge summary.The device operated as expected.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).No product is available for investigation.The most recent revision of the heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is rev.C.Section 5 entitled ¿surgical procedures¿ 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 section also outlines the steps to reorient the pump.Section 4 entitled ¿system monitor¿ 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.Changes in patient conditions can result in low flow, such as hypertension.Section 7 entitled ¿alarms and troubleshooting¿ explains all system alarms and the recommended actions associated with them.Heartmate 3 lvas patient handbook, rev.C, section 5 entitled "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.This document states that in the event of a low flow hazard alarm, call your hospital contact immediately for diagnosis and instructions.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump shipped on (b)(6) 2020.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: 11694642
• MDR Text Key: 246442014
• Report Number: 2916596-2021-01707
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• 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
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7540418
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 89