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

Model Number	MCS1705PU
Medical Device Problem Codes	Power Problem (3010); Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: d1: heartware ventricular assist system controller 2.0 d4: model #: 1420 / catalog #: 1420/ expiration date: 31-jan-2023 / serial #: (b)(6), d9: no, h3: no, h4: mfg date: 05-jan-2021, h5: no, h6: the codes present in section h6 correspond to components/products that comprise the reported event.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 reported that review of log file data it revealed motor start events with parameters outside of the typical range and low flow alarms.Also, on log file review there was an unexpected loss of power to the controller.The vad and controller remain in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
A supplemental report is being submitted for analysis and investigation completion.Product event summary: the ventricular assist device (vad) (b)(6) and one (1) controller (b)(6) were not returned for evaluation as the vad remains in use and the controller¿s location is unknown.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 motor start event recorded on 08/apr/2021 at 13:24:56, in which the motor start parameters were atypical.Log files also revealed several intermittent decreases in power consumption and estimated flows throughout the analyzed period and one (1) low flow alarm logged on (b)(6) 2025.Additionally, log file analysis revealed one (1) controller power-up event with an associated motor start event logged on 30/apr/2025 at 17:15:18 indicating a loss of power to the controller.The data point logged prior to the loss of power revealed that (b)(6) was connected to power port one (1) with 26% relative state of charge (rsoc) and (b)(6) was connected to power port two (2) with 22% 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).The controller was without power for nine (9) seconds.No anomalies were recorded leading up to the loss of power.As a result, the reported events were confirmed.Based on the available information, the device may have caused or contributed to the reported low flow event.Based on risk documentation, multiple factors may have contributed to the low flow event 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.Based on risk documentation, the most likely root cause of atypical motor start parameters may be attributed, but not limited, to outer shroud contact that creates more friction at the housing to impeller interface during pump startup.The most likely root cause of the loss of power to the controller can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.Capa pr00551638 investigated controller losses of power.Even though this capa is now closed, (b)(6) falls in scope of this capa.Additional product: d1: heartware ventricular assist system ¿ controller d4: serial #: (b)(6) h3: yes h6: the codes present in section h6 correspond to components/products that comprise the reported event.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 - PUMP
• 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: 21995205
• Report Number: 3007042319-2025-01124
• Device Sequence Number: 18220849
• Product Code: DSQ
• UDI-Device Identifier: 00888707005364
• UDI-Public: (01)00888707005364(17)230131
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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: 01/31/2023
• Device Model Number: MCS1705PU
• Device Catalogue Number: MCS1705PU
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Female