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

Model Number	1420
Medical Device Problem Codes	Use of Device Problem (1670); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received product performance data.The manufacturer's analysis subsequently revealed an unexpected loss of power.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.
Event or Problem Description
It was further reported that the loss of power was due to an accidental double disconnect of power by the patient.
Additional Manufacturer Narrative
A supplemental report is being submitted for additional information was received.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 for investigation summary.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 four (4) controller power up events with associated pump start events were logged on (b)(6) 2020 at 21:01:23 and 21:02:56, on (b)(6) 2020 at 13:34:24 and on (b)(6) 2022 at 22:19:15, indicating losses of power to the controller.The controller was without power for sixteen (16), thirteen (13), ten (10), and seventeen (17) seconds, respectively.The controller can only store a maximum of 30 days of data.After reaching the limit, the controller initiates a first-in first-out method whereby the oldest data point is deleted to allow the newest data point to be recorded.As a result, data logs prior to and following the losses of power were not available.The loss of power finding was confirmed.The most likely root cause of the losses of power logged on (b)(6) 2020 and (b)(6) 2020 can be attributed to the reported disconnection of both power sources by the patient, as described in the event details.A possible root cause of the loss of power logged on (b)(6) 2022 can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.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.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: 20351856
• Report Number: 3007042319-2024-04603
• Device Sequence Number: 7983117
• Product Code: DSQ
• UDI-Device Identifier: 00888707000475
• UDI-Public: (01)00888707000475(17)200430(2
• 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): 12/06/2024

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: 04/30/2020
• 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: 10/01/2024
• Supplement Date Received by Manufacturer: 10/02/2024; 12/05/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 10/03/2024; 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2019
• 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: 71 YR
• Patient Sex: Male