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

Model Number 1420-CONTROLLER

Device Problems Loose or Intermittent Connection (1371); Device Inoperable (1663)

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

Event Date 01/02/2018

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

Event Description

It was reported that the controller lost power after a critical battery alarm resulting in a ventricular assist device (vad) stop without an alarm.It was observed that one of the controller power ports did not always recognize a power supply.The controller was exchanged.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the controller (b)(4) was returned for evaluation.A review of the manufacturing documentation confirmed that the associated device met all requirements for release.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Failure analysis revealed that the returned controller passed visual examination and functional testing.The controller was able to recognize both power sources.Additionally, the ¿no power¿ alarm sounded as expected.Log files analysis revealed four (4) controller power-up events with their associated motor starts logged on (b)(6) 2017 at 11:33:56 and on (b)(6) 2017 at 07:07:49, 21:39:22 and 23:20:38.Several momentary disconnections were recorded on power port one leading up to the first and third losses of power.The controller was without power for 13 seconds, 8 seconds, 9 seconds and 13 seconds, respectively.As a result, the reported controller loss of power event was confirmed.No critical battery alarms were recorded within the analyzed period.As a result, the reported critical battery alarm, no sound, and ¿power source one not recognized¿ events could not be confirmed.However, the recorded momentary disconnections on power port one were likely perceived by the patient as the reported ¿power supply one was not always recognized.¿ a possible root cause of the losses of power may be attributed to a disc onnection 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.An internal investigation evaluated momentary disconnections.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: 7202457
• MDR Text Key: 97953505
• Report Number: 3007042319-2018-00277
• 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
• Report Date: 10/26/2018

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: 05/31/2018
• Device Model Number: 1420-CONTROLLER
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Initial Date Manufacturer Received: 01/02/2018
• Initial Date FDA Received: 01/17/2018
• Supplement Dates Manufacturer Received: 10/02/2018
• Supplement Dates FDA Received: 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1903-2018
• Patient Sequence Number: 1
• Treatment: UNKNOWN VAD
• Patient Age: 59 YR
• Patient Weight: 55