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

Model Number 1420

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591); Power Problem (3010)

Patient Problems Syncope (1610); Fall (1848)

Event Date 05/08/2018

Event Type  Injury  

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.Concomitant medical products: 5076-52 lead; 694765 lead implanted: (b)(6) 2010 other devices involved in this event: heartware ventricular assist system ¿ battery, battery / (b)(4)/ model #: 1650 / expiration date: 2015-08-31 udi #: asku, return date: 2018-05-22.No, device evaluation anticipated, but not yet begun; mfg date: 2014-08-31; (b)(4).Heartware ventricular assist system ¿ battery, battery / (b)(4) / model #: 1650 / expiration date: 2016-06-30, udi #: (b)(4), yes, return date: 2018-05-23; no, device evaluation anticipated, but not yet begun; mfg date: 2015-06-30; (b)(4).Heartware ventricular assist system ¿ battery, battery / (b)(4) / model #: 1650 / expiration date: 2016-09-30, udi #: (b)(4), yes, return date: 2018-05-23; device evaluation anticipated, but not yet begun; mfg date: 2015-09-30.(b)(4).Heartware ventricular assist system ¿ battery, battery / (b)(4) / model #: 1650 / expiration date: 2017-01-31, udi #: (b)(4), yes, return date: 2018-05-23.No, device evaluation anticipated, but not yet begun, mfg date: 2016-01-31.(b)(4).Heartware ventricular assist system ¿ battery, battery / (b)(4)/ model #: 1650 / expiration date: 2017-01-31, udi #: (b)(4), yes, return date: 2018-05-23.Device evaluation anticipated, but not yet begun.Mfg date: 2016-01-31.(b)(4).Heartware ventricular assist system ¿ battery, battery / (b)(4) / model #: 1650 / expiration date: 2017-01-31, udi #: (b)(4), return date: 2018-05-23, device evaluation anticipated, but not yet begun, mfg date: 2016-01-31, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient passed out and fell, which caused a minor injury with bleeding to one ear.Prior to the patient passing out, they heard an alarm and then the controller lost power.The controller and six batteries were exchanged.No further patient complications have been reported as a result of this event.

Event Description

It was further reported that the controller and batteries were involved in power switching.

Manufacturer Narrative

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.

Manufacturer Narrative

Product event summary: the controller and six batteries (bat113702, bat300864, bat303886, bat313485, bat313524, bat313718) were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Failure analysis revealed that the returned devices passed visual inspection and functional testing.Log file analysis revealed that the controller contained a feature that records whether a power source experienced a communication error or a disconnection within each 15-minute interval.Analysis of the data log files revealed several premature power switching events that were due to momentary disconnections involving bat113702, bat300864, bat303886, bat313524, and bat313718.Analysis of the event log files revealed a controller power up event on may 8, 2018 at 19:01:17.The data point prior to the controller power up, logged at 19:00:33, revealed that bat300864 was connected to power port 1 with 58% relative state of charge (rsoc) and bat113702 was connected to power port 2 with 79% rsoc.The data point after the controller power up event, logged at 19:01:52, revealed that bat300864 was connected to power port 1 and bat113702 was connected to power port 2.The controller was without power for 15 seconds.Several momentary disconnections were logged in the period leading up to the loss of power.As a result, the reported event was confirmed.The most likely root cause of the reported power switching event can be attributed to momentary disconnections between the controller and batteries.A possible root cause of the loss of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on both power sources.Internal investigations were initiated to capture events involving the controller losing power and momentary disconnections.Additional products: battery / bat113702, device evaluated by mfr: yes, fda method code(s): 10, 4112, fda results code(s): 3213, fda conclusion code(s): 12 battery / bat300864, device evaluated by mfr: yes, fda method code(s): 10, 4112, fda results code(s): 3213, fda conclusion code(s): 12 battery / bat303886, device evaluated by mfr: yes, fda method code(s): 10, 4112, fda results code(s): 3213, fda conclusion code(s): 12 battery / bat313485, device evaluated by mfr: yes, fda method code(s): 10, 4112, fda results code(s): 213, fda conclusion code(s): 67 battery / bat313524, device evaluated by mfr: yes, fda method code(s): 10, 4112, fda results code(s): 3213, fda conclusion code(s): 12 battery / bat313718, device evaluated by mfr: yes, fda method code(s): 10, 4112, fda results code(s): 3213, fda conclusion code(s): 12.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.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM- CONTROLLER 2.0
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7561280
• MDR Text Key: 109811956
• Report Number: 3007042319-2018-02177
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000420
• UDI-Public: 00888707000420
• 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: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2018
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Date Manufacturer Received: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1903-2018
• Patient Sequence Number: 1
• Treatment: 1103 VAD; 1103 VAD
• Patient Outcome(s): Other
• Patient Age: 46 YR