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

Model Number 1420

Device Problems Battery Problem (2885); Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2024

Event Type  malfunction  

Event Description

It was reported that the controller exhibited a controller fault alarm, indicating the end-of-life of the internal battery.The controller was exchanged.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that the manufacturer received product performance data.Manufacturer's analysis subsequently revealed an un expected loss of power.

Manufacturer Narrative

A supplemental is being submitted for a correction.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.

Manufacturer Narrative

A supplemental report is being submitted for investigation completion.Product event summary: the controller (b)(6) was not returned for evaluation.Review of the event log file revealed a controller power up with an associated motor start event was logged at (b)(6) 2024 at 21:01:32, 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 (b)(6) was connected to power port two (2) with 74% 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 twelve (12) seconds.No anomalies were recorded leading up to the loss of power.Log file analysis revealed a controller fault alarm was logged on (b)(6) 2024 at 21:34:54, indicating an issue with the internal battery.In addition, log files revealed that the controller had been in use for more than two (2) years.As a result, the reported controller fault alarm was confirmed.Applicable risk documentation, experience with events of similar circumstances, and the available information were considered; possible root causes of the reported controller fault alarm may be attributed, but not limited, to a reduced charge capacity of the internal battery and/or a faulty internal battery charger integrated circuit.A possible root cause of the observed loss of power 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
• Type of Device: 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 18778979
• MDR Text Key: 336958891
• Report Number: 3007042319-2024-01074
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2024

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 04/26/2024; 05/03/2024
• Supplement Dates FDA Received: 05/01/2024; 05/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 1104 VAD
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 90 KG