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

Model Number	1403
Medical Device Problem Codes	Battery Problem (2885); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the controller exhibited a controller fault alarm due to a depleted internal battery.The controller also exhibited an unexpected power loss.The controller was exchanged.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
A supplemental correction is being submitted.D4 is being correction from 1420-controller to 1403 investigation of this event is pending and a supplemental report will be sent upon its completion.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.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.
Additional Manufacturer Narrative
This supplemental is being submitted for completed analysis and investigation.Product event summary: the controller was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Failure analysis of the returned device revealed that the controller passed visual inspection and functional testing.The no power alarm performed as intended and there was no indication of an abnormality with the internal nickel-metal hydride (nimh) battery that powers the no power alarm.A review of the alarm log file revealed 29 critical battery alarms and 7 controller fault alarms logged on (b)(6) 2020 starting at 05:56:54.The critical battery alarms were the result of the patient allowing the batteries to deplete below 10% relative state of charge (rsoc).Log file analysis revealed that, at the time of the first critical battery alarm, bat313518 was connected to power port one (1) with 9% rsoc and bat314799 was connected to power port two (2) with 11% rsoc.Both batteries were then allowed to continue depleting, thus triggering controller fault alarms, which will occur if a battery is approaching 0% rsoc.Six (6) controller fault alarms were logged starting at 06:27:06 due to a battery approaching 0% rsoc.Log file analysis revealed a controller power up event at 07:29:35.The data point recorded before the power up event revealed that bat313518 was connected to power port one (1) and bat314799 was connected to power port two (2); both batteries were allowed to deplete completely, resulting in a loss of power to the controller.Several additional power up events were then logged between 07:41:58 and 09:11:45.The controller was without power for a maximum of 2 hours, 48 minutes, and 21 seconds.Additionally, a controller fault alarm was logged at 07:45:26 due to a fault in the controller¿s active power selection (aps) circuit.The aps circuit manages the selection of the active power source.When the main integrated chip senses that the current from the aps circuit is outside the normal or expected range, a controller fault alarm is triggered.The controller fault alarm was likely triggered due to the depleted batteries being connected to the controller with a very low rsoc and a low output voltage, resulting in a current below the expected range in the aps circuit.As a result, the reported controller fault alarm event was confirmed.However, the reported depleted internal battery event could not be confirmed.The most likely root cause of the observed critical battery alarms, reported controller fault alarms, and loss of power can be attributed to the patient allowing batteries to depleting below 10%.The batteries likely recovered enough charge to start the controller again, but quickly depleted, causing additional controller power up events.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.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
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 11109519
• Report Number: 3007042319-2021-00010
• Device Sequence Number: 17108431
• Product Code: DSQ
• UDI-Device Identifier: 00888707000116
• UDI-Public: 00888707000116
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2016
• Device Model Number: 1403
• Device Catalogue Number: 1403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 02/18/2021; 03/25/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 03/02/2021; 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1103 VAD
• Patient Age: 69 YR
• Patient Weight: 96