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

Model Number 1104

Device Problems Failure to Pump (1502); Pumping Stopped (1503)

Patient Problem Insufficient Information (4580)

Event Date 08/08/2022

Event Type  Death  

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 reported that the ventricular assist device (vad) stopped and failed to restart while the patient was at home, and the patient subsequently expired.

Event Description

It was further reported that the controller exhibited several vad stopped alarm and loss of power.

Manufacturer Narrative

A supplemental report is being submitted for additional event details.The event description and the additional device has been updated additional products: d1: heartware ventricular assist system ¿ controller 2.0 d4: model #: 1420 / catalog #: 1420 / expiration date: 31-mar-2020 / serial #: (b)(6), udi #:(b)(4), d9: no h3: no, device evaluation anticipated, but not yet begun, yes, delete h3 if no pending analysis (return or log file) h4: mfg date: 06-mar-2019 h5: no h6: patient ime code(s): e2401 h6: imf code(s): f02 h6: img code(s): g04035, h6: fda device code(s): a141204 h6: fda method code(s): b21 h6: fda results code(s): c21 h6: fda conclusion code(s): d16 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.

Manufacturer Narrative

A supplemental report is being submitted for device evaluation.Additional products: serial #: (b)(6) h3: yes h6:fda method code(s): b01, b15 h6: fda results code(s): c15, c19 h6: fda conclusion code(s): d10, d11, d15 h6: patient img code(s): g04034 product event summary: the ventricular assist device (vad) (b)(6) and the controller (b)(6) were returned for evaluation.A review of the pump's manufacturing documentation confirmed that the associated device met all requirements for release.Failure analysis of the returned controller revealed that the controller passed functional testing.Visual inspection revealed contamination in both power ports.This is an additional finding not related to the reported event.The most likely root cause of the observed contamination within the controller ports can be attributed to handling of the device.Failure analysis of the returned pump revealed that the device passed visual examination and functional testing.Internal pathological report revealed no evidence of thrombus within the device.Dimensional verification revealed that the front preload measurement and front housing disc curvature were found to be deviating from release specifications.Capa pr00578223 was opened to investigate post-explant issues found during failure analysis of returned pumps.Further analysis revealed outer shroud contact that created more friction at the housing to impeller interface, this increase in friction is being investigated under the capa pr00532915 investigation.Review of the controller log files revealed that this event was initiated by a controller power up event logged on 08/aug/2022 at 19:59:53.The data point recorded in the controller's internal logs prior to the loss of power revealed that (b)(6) was connected to power port one (1) with 23% relative state of charge (rsoc) and (b)(6) was connected to power port two (2) with 65% rsoc.The data point recorded after the loss of power revealed that no power source was connected to power port (1) and an active adapter was connected to power port two (2).No anomalies were observed leading up to the loss of power.The controller was without power for seventeen (17) seconds.Analysis of the alarm log file then revealed a vad stopped alarm logged on 08/aug/2022 at 20:00:22, indicating that the pump failed to restart after several attempts.This vad stopped alarm was followed by additional controller power up events and five (5) additional vad stopped alarms due to a failure of the pump to restart after multiple attempts, likely due to troubleshooting.As a result, the reported event was confirmed.A possible root cause of the initial loss of power event 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.Based on the available information, the most likely root cause of the remaining controller power up events can be attributed to troubleshooting of the vad stopped alarms.The most likely root cause of the reported vad stopped alarms can be attributed to failure of the pump to restart after several attempts.(b)(6) was not in scope of (b)(4).Capa pr00532915 is investigating pump failures to restart outside the subpopulation of (b)(4).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.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
• 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: 15218076
• MDR Text Key: 297793509
• Report Number: 3007042319-2022-06923
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2021
• Device Model Number: 1104
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Male