MAUDE Adverse Event Report: HEARTWARE, INC HEARTWARE VENTRICULAR ASSIST SYSTEM- LVAD PUMP; CIRCULATORY ASSIST SYSTEM

Catalog Number 1104

Device Problem Failure to Pump (1502)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2017

Event Type  malfunction  

Manufacturer Narrative

Additional devices added for this event: serial (b)(4) catalog# 1407de exp.Date: 07/31/2013, device available for evaluation?: no, not returned to manufacturer, labeled for single use?: no, (b)(4).Serial (b)(4) catalog# 1420 exp.Date: 04/30/2018, device available for evaluation?: no, not returned to manufacturer, labeled for single use?: no, (b)(4).Serial (b)(4) catalog# 1420 exp.Date: 05/31/2018, device available for evaluation?: no, not returned to manufacturer, labeled for single use?: no, (b)(4).This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation 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.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Event Description

It was reported that during a controller exchange in the clinic the pump would not restart and the power was above 25 watts (w).The backup 2.0 controller and the original 1.0 controller were attempted with the same result.The pump was stopped and the speed reduced to 1800 rpm, then a controller 2.0 was started in the pump stop mode, with speed set to 1800.The pump was connected and started in the second attempt.Speed was then set back to 2700 rpm.The patient was communicating the whole time.There were no problems after the restart of the pump.The patient was discharged home with two backup controllers.No patient complications have been reported as a result of this event.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: age/date of birth, other relevant history, implant date, date received by mfr, type of reports, type of reportable event, if follow up, what type?, device evaluated by manufacturer? and additonal mfr narrative.(b)(4)/catalog 1470de/expiration date: 30-apr-2013.Heartware will submit a supplemental report when new facts arise which materially alters information submitted in a previous mdr report.

Manufacturer Narrative

Conclusion: the pump (b)(4) and three controllers (b)(4) were not returned for evaluation.A review of the manufacturing documentation confirmed that the associated devices met all requirements for release.The reported event was confirmed via review of the controller log files, which revealed multiple vad stopped and vad disconnect alarms, as well as controller power up events, logged on (b)(6), 2017.A review of the available log files revealed that (b)(4) was initially in use at the time of the reported event.(b)(4)'s log files revealed 1 vad disconnect alarm on (b)(6), 2017.The vad disconnect was followed by a speed change, leading up to a controller exchange.This was a planned controller exchange, likely to upgrade the patient to a controller 2.0.(b)(4)'s log files revealed multiple controller power up events without an associated motor start event.One (1) vad stopped alarm was logged at 13:35:30, followed by 1 vad disconnect alarm at 13:35:37.Analysis of the alarms revealed that the motor failed to restart after multiple attempts.A controller power up event was logged at 13:36:12, without an associated motor start e vent.A second vad disconnect alarm was logged at 13:36:17.The vad disconnect alarms indicate that the driveline was physically disconnected from the controller, likely in an attempt to restart the pump.A controller power up event was logged at 13:39:07, with an associated motor start event at 13:39:48.This motor start event revealed an attempt count of 2, as well as a high motor start current of 4.6 a.After several speed changes, the controller was exchanged again.(b)(4)'s log files revealed a controller power up event at 15:28:50.Heartware investigated failures of the pump to restart at the system level (interaction between the pump and peripheral devices).Based on an extensive investigation, the likely contributing causes for failure to restart come from the presence of increased starting resistance in a very small number of implanted patients.This resistance is likely specific to the physiology of these patients, an area of limited access for further investigation.Therefore, no actionable root causes were identified.Additional devices added for this event: d4: serial # (b)(4).H3: yes h6:method codes: 3317, 3372 result codes: 213 conclusion codes: 92 d4: serial # (b)(4).H3: yes h6:method codes: 3317, 3372 result codes: 628 conclusion codes: 25 d4: serial # (b)(4).H3: yes h6:method codes: 3317, 3372 result codes: 213 conclusion codes: 92 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- LVAD PUMP
• Type of Device: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60 avenue; miami lakes FL 33014 3105
• MDR Report Key: 6786110
• MDR Text Key: 82809196
• Report Number: 3007042319-2017-02579
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR