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

Model Number	1103
Medical Device Problem Codes	Disconnection (1171); Battery Problem (2885); Power Problem (3010); Pumping Problem (3016)
Health Effect - Clinical Code	Hypovolemia (2243)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: 694765 lead implanted on (b)(6) 2003, 5076-52 lead implanted on (b)(6) 2003 additional product: d1: heartware ventricular assist system ¿controller 2.0 d4: model#: 1420 / catalog #: 1420 / expiration date: 30-apr-2023 /serial or lot#: (b)(6), d9: no, h3: no, h4: mfg date: 25-mar-2022, h5: no, h6: the codes present in section h6 correspond to components/products that comprise the reported event.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 reported that the controller exhibited a controller fault alarm, which was attributed to the internal battery reaching the end of its useful life.Logfile review revealed unexpected power loss, believed by the ventricular assist device team to be most likely due to accidental double power disconnect, and low flow alarms with a high pulsatility waveform were noted.Hypovolemia was suspected.A controller exchange was performed, and the pump restarted without reported issues or symptoms.No patient complications have been reported as a result of this event.
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.
Event or Problem Description
It was further reported that the patient was not hospitalized and that the diuretic medications were adjusted for the hypovolemia.
Additional Manufacturer Narrative
A supplemental report is being submitted for device evaluation.Product event summary: the ventricular assist device (vad) (b)(6) was not returned for evaluation.One (1) controller (b)(6) was returned for evaluation.A review of the device history records was not performed as the reported event and analysis are not related to a manufacturing or servicing issue.Various analyses were conducted and reviewed in order to evaluate the performance of the controller (b)(6) in relation to the reported event.Visual inspection revealed contamination within both power ports.An internal inspection revealed a crack on a standoff post within the controller housing.The observed contamination and the crack are additional findings not related to the reported event.The most likely root cause of the observed contamination can be attributed to the handling of the device.Based on an investigation, the root cause of the standoff post crack was determined to be due to mineral oil applied to the controller¿s internal main gasket and/or to the silicone adhesive applied around the controller¿s internal battery coming in to contact with the standoff post.The mineral oil and/or silicone adhesive contributed to environmental stress cracking.Capa pr00517125 is investigating this issue.Functional testing of the controller revealed that the no power alarm only sounded briefly when both power sources were disconnected from the controller and a controller fault alarm was triggered during testing, indicating an issue with the internal battery.Internal inspection revealed that the internal nickel-metal hydride (nimh) battery, which powers the no power alarm, was swollen.After the internal battery was replaced, the controller performed as intended.Log file analysis revealed intermittent decreases in power consumption and estimated flows, as well as increased pulsatility within the analyzed period.In addition, log files five (5) low flow alarms were logged since (b)(6) 2025.Log file analysis associated with (b)(6) revealed that a controller power up event with an associated motor start event was logged on 07/dec/2025 at 20:42:56, indicating a loss of power to the controller.The data point recorded prior to the loss of power revealed that no power source was connected to power port one (1) and (b)(6) was connected to power port two (2) with 85% relative state of charge (rsoc).The data point recorded after the loss of power revealed that no power source was connected to power port one (1) and (b)(6) was connected to power port two (2).The controller was without power for twelve (12) seconds.No anomalies were recorded leading up to the loss of power.Log file analysis also revealed two (2) controller fault alarms logged on (b)(6) 2025 at 21:23:24 and on (b)(6) 2025 at 09:25:10, indicating an issue with the internal battery.In addition, log file analysis revealed that the controller was in use for more than two (2) years.Review of the alarm log file revealed one (1) vad disconnect alarm was logged on (b)(6) 2025 at 12:02:39, indicating a physical disconnection of the driveline, likely during the reported controller exchange.Of note, (b)(6) is loaded with the alternate software for the pump start algorithm.As a result, the reported events were confirmed.Based on the available information, the device may have caused or contributed to the reported event.Based on the risk documentation, possible causes of the reported low flow event 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.Per the instructions for use, possible root causes of changes in pulsatility can be attributed to patient conditions including left ventricular contractility, right heart function and left ventricular afterload, which can be affected by pump rotational speed.The most likely root cause of the vad disconnect alarm can be attributed to a physical disconnection of the driveline from the controller.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.The most likely root cause of the reported controller fault alarm event can be attributed to a reduced charge capacity of the internal nimh battery.Capa pr00492825 investigated internal battery issues with controller 2.0.Even though this capa is closed, (b)(6) falls within the bounds of this capa.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.Additional products: d1: controller d4: (b)(6) d9: yes, return date: 16-dec-2025 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: 23789114
• Report Number: 3007042319-2025-02517
• Device Sequence Number: 10470019
• Product Code: DSQ
• UDI-Device Identifier: 00888707000017
• UDI-Public: (01)00888707000017(17)181231
• 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
• Device Implanted Year: 2017
• Serviced by Third Party (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): 01/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2018
• Device Model Number: 1103
• Device Catalogue Number: 1103
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 01/15/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 12/19/2025; 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DTBA1D1 ICD, 419488 LEAD.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 63 KG