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

Model Number 1103

Device Problems Disconnection (1171); Failure to Pump (1502); Pumping Problem (3016)

Patient Problem Cardiac Arrest (1762)

Event Date 08/24/2022

Event Type  Death  

Event Description

It was reported that there was an unexpected loss of power to the controller and the pump exhibited ventricular assist device (vad) stopped alarms.Emergency medical services (ems) was called and stated the controller alarm said ¿change controller.¿ the controller was exchanged but the vad did not restart.Also, the second controller exhibited a loss of power, and the event was associated with vad disconnect alarms.In addition, review of logfiles showed low flow alarms that occurred two weeks prior.The patient had been receiving compressions for approximately 40 minutes once they arrived at the hospital with the patient.It was further reported that the patient expired.

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: brand name: heartware ventricular assist system ¿ controller 2.0, model #: 1420 / catalog #: 1420 / expiration date: 30-nov-2021 / serial #: (b)(4), udi #: (b)(4), device available for evaluation: no, device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun, device mfg date: 19-nov-2020, labeled for single use: no, (b)(4).Brand name: heartware ventricular assist system ¿ controller 2.0, model #: 1420 / catalog #: 1420 / expiration date: 31-oct-2018/ serial #: (b)(4), udi #: (b)(4), device available for evaluation: no, device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun, device mfg date: 13-oct-2017, labeled for single use: no, (b)(4).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.Product event summary: the pump ((b)(6)) and two (2) controllers ((b)(6)) were not returned for evaluation.Log file analysis revealed that (b)(6) was the primary controller, initially in use during the reported event date.Log file analysis revealed thirteen (13) low flow alarms have been logged since 13/aug/2022.Review of the event log file associated with (b)(6) revealed this event was initiated by a controller power up event logged on (b)(6) 2022 at 05:22:40.The data point prior to the loss of power revealed that (b)(6) was connected to power port one (1) with 32% relative state of charge (rsoc) and (b)(6) was connected to power port two (2) with 79% rsoc.The data point recorded after the loss of power revealed that (b)(6) was connected to power port (1) and (b)(6) was connected to power port two (2).No anomalies were observed leading up to the loss of power.The controller was without power for thirteen (13) seconds.Review of the alarm log file associated with (b)(6) then revealed a vad stopped alarm was then logged on 05:23:20, indicating that the pump failed to start after multiple attempts.This vad stopped alarm was fo llowed by an additional controller power up events and an additional vad stopped alarm indicating that the pump failed to start after multiple attempts, likely due to troubleshooting and the reported controller exchange.Review of the log files associated with con314173 revealed a controller power up event logged on (b)(6) 2022 at 06:43:35.Prior to the power up event, the controller last had power on (b)(6) 2019, indicating that the controller was put into use following the reported controller exchange.Review of the alarm log file associated with con314173 then revealed a vad stopped alarm was logged on (b)(6) 2022 at 06:43:56, indicating that the pump failed to restart after several attempts.This vad stopped alarm was followed by vad disconnect alarms indicating a physical disconnection of the driveline from the controller, additional controller power up events, and an additional vad stopped alarm indicating that the pump failed to start after multiple attempts, likely due to troubleshooting.As a result, the reported events were confirmed.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.A possible root cause of the initial 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.The most likely root cause of the remaining controller power up events involving the controllers can be attributed to a controller exchange and troubleshooting of the vad stopped alarms.The most likely root cause of the vad disconnect alarms can be attributed to physical disconnections of the driveline from the controller during troubleshooting of the vad stopped alarms.The most likely root cause of the vad stopped alarms can be attributed to failure of the pump to restart after several attempts.(b)(6) was not in scope of fca cvg-21-q3-21.Capa pr00532915 is investigating pump failures to restart outside the subpopulation of fca cvg-21-q3-21.Additional products: d4: serial #: (b)(6), h3: yes h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d10, d15 d4: serial #: (b)(6), h3: yes h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d10 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: 15380092
• MDR Text Key: 299477163
• Report Number: 3007042319-2022-07196
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707002639
• UDI-Public: 00888707002639
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 09/08/2022
• Supplement Dates Manufacturer Received: 12/15/2022
• Supplement Dates FDA Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2018
• 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
• Treatment: DDMB1D4 ICD, 5076-52 LEAD, 6935M55 LEAD
• Patient Outcome(s): Death
• Patient Age: 60 YR
• Patient Sex: Male