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

Model Number 1420

Device Problem Device Inoperable (1663)

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

Event Date 04/13/2018

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.Concomitant medical products: d314vrg icd, and 6944-58 lead, implanted on: (b)(6) 2012.Other devices involved in this event: brand name: heartware ventricular assist system - battery: battery / (b)(4) / model #:1650de / expiration date: 03/31/2018, udi #: (b)(4), device available for evaluation: yes, return date: 05/02/2018, device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun, device manufacture date: mfg date: 03/31/2017, labeled for single use: no.Other devices involved in this event: brand name: heartware ventricular assist system - battery: battery / (b)(4) / model #:1650de / expiration date: 03/31/2018, udi #: (b)(4), device available for evaluation: yes, return date: 05/02/2018, device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun, device manufacture date: mfg date: 03/31/2017, labeled for single use: no.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 associated batteries exhibited no power and a vad start up.The batteries were exchanged and the controller remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: two batteries (b)(4) were returned for evaluation.The controller (b)(4) was not 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 of the returned batteries revealed that the devices passed visual examination and functional testing.Log file analysis revealed a controller power up event on (b)(6), 2018 at 00:23:29.The data point prior to the controller loss of power, logged at 00:09:42 revealed that (b)(4) was connected to power port one (1) with 49% relative state of charge (rsoc) and (b)(4) was connected to power port two (2) with 95% rsoc.The data point after the controller power up event, logged at 00:24:04, revealed that (b)(4) was connected to power port one (1) and (b)(4) was connected to power port two (2).The controller was without power for 6 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.Battery (b)(4).D4: expiration date: 2018-03-31 udi #: (b)(4).H3: yes h4: mfg date: 2017-03-31 h6: fda method code(s): 10, 4112 h6: fda results code(s): 213 h6: fda conclusion code(s): 67 battery (b)(4).D4: expiration date: 2018-03-31 udi #: (b)(4).H3: yes h4: mfg date: 2017-03-31 h6: fda method code(s): 10, 4112 h6: fda results code(s): 213 h6: 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.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 (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7493913
• MDR Text Key: 107576220
• Report Number: 3007042319-2018-01779
• 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
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2018
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (B)(4).; 1103 VAD
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Weight: 89