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

Model Number 1103

Device Problem Failure to Pump (1502)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/29/2019

Event Type  Injury  

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.Concomitant medical products: 429688 - lead, implanted: (b)(6) 2014, 5076-45 - lead, implanted: (b)(6) 2014, 6947m55 lead, implanted: (b)(6) 2014.Additional products: brand name: heartware ventricular assist system, controller 2.0: model #: 1420 / catalog #: 1420 / expiration date: 30nov2019 / serial or lot#: (b)(4), udi #: (b)(4).Device available for evaluation: yes, return date: 01nov2019.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes.Mfg date: 27nov2019.Labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system, controller 2.0.Model #: 1420 / catalog #: 1420 / expiration date: 30nov2019 / serial or lot#: (b)(4), udi #: (b)(4).Device available for evaluation: yes, return date: 01nov2019.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes.Mfg date: 27nov2019.Labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system, battery, model #: 1650de / catalog #: 1650de / expiration date: 31dec2019 / serial or lot#: (b)(4), udi #: (b)(4).Device available for evaluation: no.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Mfg date: 13dec2019.Labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system battery, model #: 1650de / catalog #: 1650de / expiration date: 31dec2019 / serial or lot#: (b)(4), udi #: (b)(4).Device available for evaluation: no.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Mfg date: 13dec2019.Labeled for single use: no.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the batteries exhibited power disconnect alarms followed by a loss of power to the controller.The controller regained power, however it was further reported that the controller exhibited a ventricular assist device (vad) stop alarm and the patient performed a controller exchange.The controller exchange did not eliminate the vad stop alarms and the pump did not restart.The patient presented to the hospital, where it was noted that the controller was connected to two power sources and the drive line but both the pump and controller were off, with the controller screen reportedly blank.Since the pump was off for almost two hours, the decision was made to replace it to prevent the risk of emboli and stroke.The ventricular assist device (vad) and controllers were exchanged, and the batteries remain in use.The patient remained intubated on vasopressors, but off inotropes.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the ventricular assist device (vad) and two (2) controllers were returned for evaluation.Two (2) batteries were not returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Failure analysis of the returned controllers revealed that the devices passed visual inspection and functional testing.Failure analysis of the returned pump revealed that the device passed visual examination, functional testing, and dimensional verification.Internal pathological report revealed no evidence of thrombus within the device.Review of the controller log files associated with controller (b)(6) revealed a controller power up event on(b)(6) 2019, at 14:05:10.The data point 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 96% rsoc.The data point recorded after the loss of power revealed that no power source was connected to power port one (1) and (b)(6) was connected to power port two (2).The controller was without power for 14 seconds.A vad stopped alarm was logged at 14:05:59 indicating that the pump failed to restart after multiple attempts.Four (4) power disconnect alarms were logged from 14:07:20 through 14:10:12 involving the reported batteries.During the power disconnect alarms, a safety alert word (saw) value was recorded indicating an over current alert.The event log recorded a high-power consumption during the attempted motor start, which required more current from the batteries.The batteries were most likely physically disconnected by the patient shortly after, causing the controller to log this event as a power disconnect alarm.A vad d is connect alarm was logged at 14:10:52 due to the physical disconnection of the driveline from the controller.This was followed by multiple additional controller power up events and vad disconnect alarms, likely due to troubleshooting of the controller.Review of the controller log files associated with controller (b)(6) revealed a controller power up event on (b)(6) 2019, at 14:13:10.A vad disconnect alarm was logged following the controller power up at 14:13:36, indicating that the controller was powered up without the driveline cable connected, likely in preparation for a controller exchange.A vad stopped alarm was logged at 14:15:06 indicating that the pump failed to restart after multiple attempts.This was followed by multiple additional controller power up events and vad disconnect alarms, likely due to troubleshooting of the controller.As a result, the reported event was confirmed.A possible root cause of the loss of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on both power sources.A possible root cause of the reported power disconnect alarms may be attributed, but not limited, to a physical disconnection of the power source.The most likely root cause of the vad disconnect alarms observed in the log files may be attributed to a physical disconnection of the driveline from the controller.The most likely root cause of the vad stopped alarms can be attributed to failure of the pump to restart after several attempts.An internal investigation evaluated failures of the pump to restart at the system level (interaction between the pump and peripheral devices).Based on an extensive investigation conducted, the likely contributing cause for failure to restart was the inability of the pump-start algorithm to provide sufficient torque to overcome abnormally high mechanical resistance caused by unknown conditions that existed prior to the failed restart attempt.Another internal investigation was initiated to capture events involving the controller losing power.Additional products: d4: serial or lot#: (b)(6), h3: yes, h6: fda method code(s): 10, 4112, h6: fda results code(s): 213, h6: fda conclusion code(s): 4310, d4: serial or lot#: (b)(6) h3: yes, h6: fda method code(s): 10, 4112, h6: fda results code(s): 213 ,h6: fda conclusion code(s): 4310, d4: serial or lot#: (b)(6) h3: yes, h6: fda method code(s): 4112, 4114, h6: fda results code(s): 213, h6: fda conclusion code(s): 67, d4: serial or lot#: (b)(6) h3: yes, h6: fda method code(s): 4112, 4114, h6: fda results code(s): 213, h6: fda conclusion code(s): 67.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 additional information.Additional information was received regarding the recall number.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.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 analysis.H6: the codes present in section h6 correspond to components/products that comprise the reported event.Product event summary: the pump (b)(6) and two (2) controllers ((b)(6)) were returned for evaluation.Two (2) batt eries ((b)(6)) were not returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Review of (b)(6) manufacturing documentation confirmed that the associated device met all requirements for release.Failure analysis of the returned controllers revealed that the devices passed visual inspection and functional testing.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 was found to be deviating from the specification.Capa pr00578223 was opened to investigate post-explant issues found during failure analysis of returned pumps.Dimensional verification also revealed that the front housing disc curvature was found to be deviating from specifications.Further analysis revealed that the impeller could potentially contact the front housing at its outer shroud, which leads to increased starting friction at the housing to impeller interface; this increase in friction was investigated under the capa pr00502194 investigation.Review of the controller log files associated with controller, (b)(6), revealed a controller power up event on (b)(6) 2019, at 14 :05:10.The data point 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 96% rsoc.The data point recorded after the loss of power revealed that no power source was connected to power port one (1) and (b)(6) was connected to power port two (2).The controller was without power for 14 seconds.A vad stopped alarm was logged at 14:05:59 indicating that the pump failed to restart after multiple attempts.Four (4) power disconnect alarms were logged from 14:07:20 through 14:10:12 involving (b)(6).During the power disconnect alarms, a safety alert word (saw) value was recorded indicating an overcurrent alert.The event log recorded a high-power consumption during the attempted motor start, which required more current from the batteries.The batteries were most likely physically disconnected by the patient shortly after, causing the controller to log this event as a power disconnect alarm.A vad disconnect alarm was logged at 14:10:52 due to the physical disconnection of the driveline from the controller.This was followed by multiple additional controller power up events and vad disconnect alarms, likely due to troubleshooting of the controller.Review of the controller log files associated with controller, (b)(6), revealed a controller power up event on (b)(6) 2019, at 14:13:10.A vad disconnect alarm was logged following the controller power up at 14:13:36, indicating that the controller was powered up without the driveline cable connected, likely in preparation for a controller exchange.A vad stopped alarm was logged at 14:15:06 indicating that the pump failed to restart after multiple attempts.This was followed by multiple additional controller power up events and vad disconnect alarms, likely due to troubleshooting of the controller.As a result, the reported event was confirmed.A possible root cause of the 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.A possible root cause of the reported power disconnect alarms may be attributed, but not limited, to a physical disconnection of the power source.The most likely root cause of the vad disconnect alarms observed in the log files may be attributed to a physical disconnection of the driveline from the co ntroller.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) is part of fca cvg-21-q3-21.Capa pr00502194 investigated pump failures to restart.Based on an investigation conduct ed under capa pr00502194, the most likely root cause of the failure to restart event may be attributed to outer shroud contact that created more friction at the housing to impeller interface.Even though this capa is now closed, (b)(6) falls within the bounds of this capa.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: 9291884
• MDR Text Key: 166961522
• Report Number: 3007042319-2019-12436
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707003261
• UDI-Public: 00888707003261
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0946-2021
• Patient Sequence Number: 1
• Treatment: DTMA1D4 - BI-VENTRICULAR DEFIB
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 67 KG