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	06/15/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The manufacturer received product performance data.Manufacturer's analysis subsequently revealed an unexpected loss of power.The c controller remains in use.No patient complications have been reported as a result of this event.
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 analysis and investigation completion.Product event summary: the controller (b)(6) was not returned for evaluation.No performance allegations were made against the device; therefore, the purpose of this investigation is solely to address the finding identified during analysis of the controller log files.A review of the manufacturing documentation was not performed as the reported event and analysis are not related to a manufacturing or servicing issue.Log file analysis revealed a controller power up event, with an associated motor start event, logged on (b)(6) 2025 at 22:22:01, indicating a loss of power to the controller.The data point recorded prior to the loss of power revealed that (b)(6) was connected to power port one (1) with 24% relative state of charge (rsoc) and that no power source was connected to power port two (2).The data point recorded after the loss of power revealed that (b)(6) was connected to power port one (1) and a power adapter was connected to power port two (2).The controller was without power for approximately ten (10) seconds.No anomalies were recorded leading up to the loss of power.As a result, the loss of power finding was confirmed.Review of the alarm log file revealed one (1) low flow alarm was logged on (b)(6) 2025.The low flow alarm is an additional finding unrelated to the reported finding.The most likely root cause of the loss of power finding can be attributed to the double disconnection of power sources, as described in the event details.Capa pr00551638 investigated controller losses of power.Even though this capa is now closed, (b)(6) falls in scope of this capa.Based on the available information, the device may have caused or contributed to the observed low flow finding.Based on the risk documentation, possible causes of the observed low flow finding may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, poor vad filling, and/or inappropriate pump rotational speed.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.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.

• 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 55112-4391 ; 7635269277
• MDR Report Key: 22862088
• Report Number: 3007042319-2025-01934
• Device Sequence Number: 18050325
• Product Code: DSQ
• UDI-Device Identifier: 00888707006859
• UDI-Public: (01)00888707006859(17)CON411923
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2025

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: 05/31/2021
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: 08/28/2025; 09/17/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 08/29/2025; 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2020
• 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
• Patient Age: 46 YR
• Patient Sex: Male