MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0; VENTRICULAR (ASSIST) BYPASS

Model Number 1420-CONTROLLER

Device Problems No Audible Alarm (1019); Device Inoperable (1663)

Patient Problem Dizziness (2194)

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was lightheaded after the controller lost power resulting in three pump stops while failing to sound any alarms.The controller will be exchanged.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Correction: b3.This event was assessed and is being reported as part of a retrospective review of log file data.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: the controller was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Failure analysis of the returned controller revealed that the device passed functional testing.The no power alarm worked as intended during testing.Visual inspection revealed a missing serial cap and contamination in the serial port of the controller.These are additional observations not related to the reported event, likely due to handling of the device.Additionally, a visual inspection under 10x magnification revealed hairline cracks around power ports one and two.An internal inspection did not reveal evidence of fluid ingress.These findings are not related to the reported event.Based on an internal investigation, the root cause of the hairline cracks was determined to be due to chemical additives applied to the power port gaskets during the manufacturing process.The chemical additives contributed to environmental stress cracking.Log file analysis revealed six controller power-up events, with their associated motor start events, logged between (b)(6) 2018 and (b)(6) 2018.The controller was without power for 30 seconds, 8 seconds, 13 seconds, 7 seconds, 18 seconds, and 10 seconds respectively.Of note, several momentary disconnections were observed leading up to multiple of the loss of power events.As a result, the reported loss of power event was confirmed.Additionally, analysis of the event log file revealed that the controller had experienced a corruption resulting in error conditions on (b)(6) 2018.This corruption forced the user interface controller, which is the main integrated chip responsible for the operations of the controller, to reset, which would appear as controller power loss events to the pa tient.However, in these instances, the pump motor controller, which is responsible for capturing pump parameters and monitoring and maintaining the pump at the desired speed, was not impacted and the pump continued to run.Additionally, the no power alarm would not have sounded in these instances, as the controller did not lose power.As a result, the reported "no sound" event was confirmed.A possible root cause of the losses of power can be attributed to disconnections of both power sources and/or to intermittent disconnections on both power sources.Based on the available information, the most likely root cause of the "no sound" event may be attributed to a corruption of the uic resulting in resets on (b)(6) 2018, which were likely perceived by the patient as losses of power.An internal investigation was initiated to capture events involving the controller losing power.An internal investigation evaluated momentary disconnections.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7634347
• MDR Text Key: 112220328
• Report Number: 3007042319-2018-02692
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000475
• UDI-Public: 00888707000475
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Model Number: 1420-CONTROLLER
• Device Catalogue Number: 1420-CONTROLLER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Date Manufacturer Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1903-2018
• Patient Sequence Number: 1
• Treatment: MCS VAD; MCS VAD
• Patient Age: 45 YR
• Patient Weight: 143