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

Model Number 1407DE

Device Problems Electrical /Electronic Property Problem (1198); Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2018

Event Type  malfunction  

Manufacturer Narrative

This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient's controller failed and controller display advised to exchange controller.There was a pump stop associated with the event.The controller was exchanged.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The controller, (b)(4) was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Failure analysis of the returned controller revealed that the device passed visual inspection and functional testing.Review of the log files revealed an electrical fault alarm, a high watt alarm, and 2 vad stopped alarms logged on (b)(6) 2018.An electrical fault alarm was logged at 10:07:06 due to an open phase in the front stator, causing the pump to run on the rear stator only.In addition, multiple reactivation events were recorded in the event file due to open phases in the front stator.This likely triggered the subsequent high watt alarm, due to the increased power consumption required to run on a single stator.A vad stopped alarm was logged at 10:07:17 due to vad minimum speed failure (below 1400rpm for 10 seconds).This corresponds with the reported controller failure with associated pump stop and the ¿exchange controller¿ message on the controller display.A second vad stopped alarm was logged at 10:09:03 due to a failure of the pump to restart after several attempts.As a result, the reported event was confirmed.Based on the available information, a possible root cause of the reported event can be attributed, but not limited, to contamination by foreign material of the driveline connector or a marginal driveline connection.The most likely root cause of the vad stopped alarm can be attributed to failure of the pump to restart after several attempts.Based on an extensive internal investigation of failures of the pump to restart at the system level (interaction between the pump and peripheral devices), the likely contributing causes for failure to restart come from the presence of increased starting resistance in a very small number of implanted patients.This resistance is likely specific to the physiology of these patients, an area of limited access for further investigation.Therefore, no actionable root causes were identified.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A supplemental report is being submitted for additional information, investigation completion, and correction.Correction b5: event description was corrected to include a statement regarding the disposition of the ventricular assist device (vad).Correction h10: section h10 was corrected to include device and code information for the vad associated with the event.Additional information was received regarding the recall number.Product event summary: the pump was not returned for evaluation.The controller was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Failure analysis of the returned controller revealed that the device passed visual inspection and functional testing.Review of the log files revealed an electrical fault alarm, a high watt alarm, and 2 vad stopped alarms logged on (b)(6) 2018.An electrical fault alarm was logged at 10:07:06 due to an open phase in the front stator, causing the pump to run on the rear stator only.In addition, multiple reactivation events were recorded in the event file due to open phases in the front stator.This likely triggered the subsequent high watt alarm, due to the increased power consumption required to run on a single stator.A vad stopped alarm was logged at 10:07:17 due to vad minimum speed failure (below 1400rpm for 10 seconds).This corresponds with the reported controller failure with associated pump stop and the ¿exchange controller¿ message on the controller display.A second vad stopped alarm was logged at 10:09:03 due to a failure of the pump to restart after several attempts.As a result, the reported event was confirmed.Based on the available information, a possible root cause of the reported event can be attributed, but not limited, to contamination by foreign material of the driveline connector or a marginal driveline connection.The most likely root cause of the remaining vad stopped alarm can be attributed to failure of the pump to restart after several attempts.Capa pr00502194 is investigating pump failures to restart.Additional products: d1: heartware ventricular assist system ¿ pump d4: model #: 1103 / catalog #: 1103 / expiration date: 30-nov-2019 / serial #: (b)(6) udi #: (b)(4) d9: no h3: yes h4: mfg date: 06-nov-2017 h5: yes h6: patient ime code(s): e2403 h6: imf code(s): f26 h6: fda device code(s): a141204 h6: fda method code(s): b15, b17 h6: fda results code(s): c04, c19 h6: fda conclusion code(s): d10, d15 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 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 ventricular assist device (vad) remains in use.

Manufacturer Narrative

A supplemental report is being submitted as a new internal investigation has been assigned to this event, also updated h6 codes.Additional products: d4: hw30953 h6: img code(s): g04105 h6: fda results code(s): c21 h6: fda conclusion code(s): d16 the ventricular assist device (vad) hw30953 is not in scope of capa (b)(4) and capa (b)(4) was initiated to investigate pump failures to restart outside the subpopulation of capa (b)(4).An internal investigation is pending.A report will be sent when root cause for the internal investigation has been determined.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.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM-CONTROLLER
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7469916
• MDR Text Key: 106960423
• Report Number: 3007042319-2018-01639
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Model Number: 1407DE
• Device Catalogue Number: 1407DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0946-2021
• Patient Sequence Number: 1