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

Model Number	MCS1705PU
Medical Device Problem Codes	Disconnection (1171); Electrical /Electronic Property Problem (1198); Loose or Intermittent Connection (1371); Pumping Stopped (1503); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
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-may-2025 / serial #: (b)(6) d9: no h3: no h4: mfg date: 24-may-2024 h5: no h6: the codes present in section h6 correspond to components/products that comprise the reported event.D1: heartware ventricular assist system - driveline cover d4: model #: 1175 / catalog #: 1175 / expiration date: / lot #: d9: no h3: no h4: mfg date: 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.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 while a patient with a history of cardiomyopathy was on a hospital unit, an electrical fault alarm was triggered on the ventricular assist device (vad).Upon investigation, it was found that the driveline was partially disconnected from the controller.The nurse reconnected the driveline, resolving the alarm.Logfiles data indicated two disconnect alarms during this period.An engineer inspected the driveline and found it secure but noted that the driveline cover was loose and suspected it may have contributed to the disconnection.The patient refused the removal of the driveline cover despite recommendations.The site will continue to discuss options with the patient.Additionally, a vad stop alarm was noted.The vad, driveline cover, 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 additional information received.Updated additional products.Additional products: d1: heartware ventricular assist system - driveline cover d4: lot #: r025326 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
A supplemental report is being submitted for investigation summary.Additional products: serial# (b)(6) h3: yes lot# r025326 h3: yes h6: the codes present in section h6 correspond to components/products that comprise the reported event.Product event summary: the ventricular assist device (vad) (b)(6), the controller ((b)(6)), and the associated driveline boot cover (lot no.R025326) were not returned for evaluation.A review of the devices¿ history records was not performed as the reported event and analysis are not related to a manufacturing or servicing issue.There was no evidence that the driveline boot cover had previously been serviced.Log file analysis revealed two (2) electrical fault alarms were logged on (b)(6) 2025 at 14:10:19 and 14:11:55 and seven (7) reactivation events logged between 14:10:15 and 14:11:59.The electrical fault alarm and reactivation events were due to an open phase in the front stator, resulting in single stator operation (rear stator only).Log files also revealed two (2) additional reactivation events were logged at 14:13:02 and 14:16:10, due to an open phase in the rear stator, resulting in single stator operation (front stator only).Furthermore, two (2) vad disconnect alarms were logged at 14:13:02 and 14:16:11, due to a critical phase open, indicating there was an open phase on each stator.As a result, the reported electrical fault alarms and vad disconnect alarms were confirmed.The reported loose driveline boot cover could not be confirmed due to insufficient information.Based on risk documentation and the available information, a possible root cause of the electrical fault alarms, vad disconnect alarms and the observed reactivation events can be attributed, but not limited, to contamination by foreign material of the driveline connector and/or a marginal driveline connection.Based on the limited information available, a possible root cause of the loose driveline boot cover may be attributed, but not limited, to external factors resulting in inadequate dimensions of the driveline boot cover.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 - DRIVELINE
• 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: 21986167
• Report Number: 3007042319-2025-01115
• Device Sequence Number: 19911376
• Product Code: DSQ
• UDI-Device Identifier: 00888707005364
• UDI-Public: (01)00888707005364(17)220831
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2025

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: 08/31/2022
• 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: 05/02/2025
• Supplement Date Received by Manufacturer: 07/17/2025; 07/29/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 07/24/2025; 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2020
• 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: DDBB1D4 ICD, 6935M62 LEAD, 5076-52 LEAD
• Patient Age: 73 YR
• Patient Sex: Female