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

Model Number 1420

Device Problems Disconnection (1171); Device Inoperable (1663); Use of Device Problem (1670)

Patient Problems Arrhythmia (1721); Ventricular Tachycardia (2132); Loss of consciousness (2418)

Event Date 03/24/2018

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: 1488tc lead, implanted on: (b)(6) 2004; 1156t lead, implanted on: (b)(6) 2009; 7122 lead, implanted on: (b)(6) 2012; icd, implanted on: (b)(6) 2017.Other devices involved in this event: heartware ventricular assist system - battery/(b)(4)/model #: 1650/expiration date: 2017-06-30, (b)(4), mfg date: 2016-06-30, (b)(4).Other devices involved in this event: heartware ventricular assist system - battery/(b)(4)/model #: 1650/expiration date: 2016-10-30, (b)(4), mfg date: 2015-10-30, (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 and two batteries exhibited a double power disconnect.The batteries were at greater than twenty five percent capacity when the no power alarm signalled and the patient was non-verbal and slumped over with ventricular tachycardia (vt), and cardiac arrhythmia.At battery will be exchanged, the controller and battery remain in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the controller (con312970) and batteries (bat321661, bat308239) were not returned for evaluation.Log file an alysis revealed a controller power-up event on (b)(6) 2018 at 16:16:18 with associated motor start event at 16:16:19.The data point recorded before the loss of power revealed that bat308239 was connected to power port 1 with 38% relative state of charge (rsoc) and bat312661 was connected to power port 2 with 49% rsoc.The data point after the loss of power revealed that bat312502 was connected to power port 1 and bat312661 was connected to power port 2.The controller was without power for 15 seconds.As a result, the reported event was confirmed.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.Battery bat321661 expiration date: 2017-06-30 udi #: (b)(4) mfg date: 2016-06-30 , fda method code(s): 4112, 4114 ,fda results code(s): 213 ,fda conclusion code(s): 67 battery bat308239 expiration date: 2016-10-30 udi #: (b)(4) mfg date: 2015-10-30 ,patient code(s): c50635, c2881, c50802 , device code(s): c63030 , fda conclusion code(s): 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.

Manufacturer Narrative

Correction: e1, g4, h5, h10 product event summary: the controller and two batteries were not returned for evaluation.Log file analysis revealed a controller power-up event on (b)(6) 2018 at 16:16:18.The data point recorded before the loss of power revealed that bat308239 was connected to power port one with 38% relative state of charge (rsoc) and bat312661 was connected to power port two with 49% rsoc.The data point recorded after the loss of power revealed that bat312502 was connected to power port one and bat312661 was connected to power port two.The controller was without power for 15 seconds.As a result, the reported event was confirmed.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 one or both power sources.An internal investigation was initiated to capture events involving the controller losing power.Battery bat308239 h6 fda method code(s): 4112, 4114 h6 fda results code(s): 213 h6 fda conclusion code(s): 67 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.

• 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: 7443304
• MDR Text Key: 106725308
• Report Number: 3007042319-2018-01528
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1103 VAD
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 85