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

Model Number	1420
Medical Device Problem Codes	Disconnection (1171); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the controller exhibited a power-up event and an associated pump start attempt indicating a loss of power to the controller.The controller was off for approximately 14 seconds.The controller remains in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
A supplemental report is being submitted as additional information has being received for this event and sections have been updated.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was further reported that the loss of power event occur due to a double disconnection of both power sources by the patient.
Additional Manufacturer Narrative
A supplemental report is being submitted for investigation summary.Product event summary: the controller ( (b)(6) ) was not returned for evaluation.A review of the manufacturing documentation was not performed as the reported event and analysis are not related to a manufacturing or servicing issue.Review of the controller log files revealed a controller power up event, with an associated motor start event, logged on (b)(6) 2024 at 05:53:19, indicating a loss of power to controller.The data point recorded prior to the loss of power revealed that (b)(6) was connected to power port one (1) with 36% relative state of charge (rsoc) and (b)(6) was connected to power port two (2) with 99% rsoc.The data point recorded after the loss of power revealed that (b)(6) was connected to power port one (1) and (b)(6) was connected to power port two (2).No anomalies were recorded leading up to the loss of power.The controller was without power for 14 seconds.As a result, the reported loss of power event was confirmed.A possible root cause of the loss of power event can be attributed to the double disconnection of both power s ources as described in the event details.Capa pr00551638 is investigating controller losses of power.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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635269277
• MDR Report Key: 19231165
• Report Number: 3007042319-2024-03307
• Device Sequence Number: 5920017
• Product Code: DSQ
• UDI-Device Identifier: 00888707000475
• UDI-Public: 00888707000475
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2024

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: 09/30/2019
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 05/08/2024; 07/03/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 05/14/2024; 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1103 VAD.
• Patient Age: 48 YR
• Patient Sex: Male