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

Model Number 1420

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 04/18/2018

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.Other devices involved in this event: heartware ventricular assist system -controller 2.0 / (b)(4)/model #: 1420 / expiration date: 2018-07-31 udi #: (b)(4), return date: 2018-04-24, device evaluation anticipated, but not yet begun mfg date: 2017-07-31 (b)(4).Heartware ventricular assist system -battery/ (b)(4)/model #: 1650de / expiration date: 2018-05-31 udi #: (b)(4), return date: 2018-04-24, device evaluation anticipated, but not yet begun mfg date: 2017-05-31 (b)(4).Heartware ventricular assist system -battery/ (b)(4)/model #: 1650de / expiration date: 2018-06-30 udi #:(b)(4), return date: 2018-04-24, device evaluation anticipated, but not yet begun mfg date: 2017-06-30.(b)(4).Heartware ventricular assist system -battery/ (b)(4)/model #: 1650de / expiration date: 2018-08-31 udi #: (b)(4), return date: 2018-04-24 , device evaluation anticipated, but not yet begun mfg date: 2017-08-31.(b)(4).Heartware ventricular assist system -battery / (b)(4)/model #: 1650de / expiration date: 2017-08-31 udi #: (b)(4), return date: 2018-04-24, device evaluation anticipated, but not yet begun mfg date: 2018-08-31 (b)(4).Heartware ventricular assist system -battery/ (b)(4)/ model #: 1650de / expiration date: 2017-08-31 udi #: (b)(4), return date: 2018-04-24 , device evaluation anticipated, but not yet begun mfg date: 2018-08-31 (b)(4).Heartware ventricular assist system -battery / (b)(4)/model #: 1650de / expiration date: 2017-05-31 udi #: (b)(4) mfg date: 2018-05-31(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the ventricular assist device (vad) controller exhibited loose connections, the other controller exhibited power switching, and associated batteries exhibited power switching at greater than twenty-five percent (25%) capacity.The controllers and batteries were exchanged.No patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

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 returned controller (b)(4) failed visual inspection because of a missing serial cap.It passed functional testing and system running test.Log file analysis was not required.When received controller did not have an alarm file and data file shows it only ran briefly on (b)(6) 2017.An observation was made of light contamination around connector ps1.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: two (2) controllers and five (5) batteries were returned for evaluation.One (1) battery (bat580684) was not returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the returned devices in relation to the reported event.Failure analysis of the returned controller ((b)(6)) and the five (5) returned batteries revealed that the devices passed visual examination and functional testing.Failure analysis of the returned controller (con302102) revealed that the device passed functional testing.Visual inspection of controller ((b)(6)) revealed light contamination around the connector of power source 1 (ps1) and that the serial cap was missing.These are additional observations not related to the reported event, both likely due to the handling of the device.No anomalies were observed which could affect the functionality of the connectors.As a result, the reported "loose connections" event for (b)(6) could not be confirmed.Analysis of the controller log files associated with (b)(6) revealed that the controller was not in use during the reported event date.Analysis of the controller log files associated with (b)(6) 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 power switching events due to momentary disconnections involving battery bat580787 within analyzed period.As a result, the reported power switching event was confirmed.The most likely root cause of the premature power switching event can be attributed to momentary disconnections between the controller and battery.Controller (b)(6); device evaluated by mfr: yes; fda method code(s): 10, 4112; fda results code(s): 3213; fda conclusion code(s): 12 battery bat580787; device evaluated by mfr: yes; fda method code(s): 10, 4112; fda results code(s): 3213; fda conclusion code(s): 12 battery bat581986; device evaluated by mfr: yes; fda method code(s): 10, 4112; fda results code(s): 3213; fda conclusion code(s): 12 battery bat585453; device evaluated by mfr: yes; fda method code(s): 10, 4112; fda results code(s): 213; fda conclusion code(s): 67 battery bat584555; device evaluated by mfr: yes; fda method code(s): 10, 4112; fda results code(s): 213; fda conclusion code(s): 67 battery bat585378; device evaluated by mfr: yes; fda method code(s): 10, 4112; fda results code(s): 213; fda conclusion code(s): 67 battery bat580684; fda method code(s): 4114, 4112; fda results code(s): 213; fda conclusion code(s): 67.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: 7504057
• MDR Text Key: 108647367
• Report Number: 3007042319-2018-01857
• 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,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2018
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/10/2018
• Supplement Dates Manufacturer Received: 06/29/2018; 07/17/2018; 08/08/2018; 12/20/2018
• Supplement Dates FDA Received: 07/13/2018; 07/17/2018; 10/02/2018; 12/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1903-2018
• Patient Sequence Number: 1
• Treatment: MCS UNKNOWN VAD
• Patient Age: 67 YR
• Patient Weight: 95