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

Model Number 1420

Device Problems Loose or Intermittent Connection (1371); Power Problem (3010)

Patient Problem Loss of consciousness (2418)

Event Date 02/17/2020

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 trans plantation 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.Additional products: brand name: heartware ventricular assist system  battery , medical device: model #: 1650 / catalog #: 1650 / expiration date: 28-feb-2017 / serial #: (b)(4).Udi #: (b)(4).Device available for evaluation? yes, return date: 04-mar-2020.Device evaluated by manufacturer? no, device evaluation anticipated, but not yet begun.Dev rtn to mfr? yes.Mfg date: 19-feb-2016.Labeled for single use? no.(b)(4).Brand name: heartware ventricular assist system  battery, medical device: model #: 1650 / catalog #: 1650 / expiration date: 28-feb-2017 / serial #: (b)(4).Udi #: (b)(4).Device available for evaluation? no.Device evaluated by manufacturer? no, device evaluation anticipated, but not yet begun.Mfg date: 28-feb-2016.Labeled for single use? no.(b)(4).Brand name: heartware ventricular assist system  battery : medical device model #: 1650 / catalog #: 1650 / expiration date: 31-mar-2017 / serial #: (b)(4).Udi #: (b)(4).Device available for evaluation? yes, return date: 04-mar-2020.Device evaluated by manufacturer? no, device evaluation anticipated, but not yet begun.Dev rtn to mfr? yes.Mfg date: 02-mar-2016.Labeled for single use? no.(b)(4).Brande name: heartware ventricular assist system  battery : model #: 1650 / catalog #: 1650 / expiration date: 31-mar-2018 / serial #: (b)(4).Udi #: (b)(4).Device available for evaluation? yes, return date: 04-mar-2020.No, device evaluation anticipated, but not yet begun.Dev rtn to mfr? yes.Mfg date: 31-mar-2017.No.(b)(4).Brand name: heartware ventricular assist system  battery, medical device: model #: 1650 / catalog #: 1650 / expiration date: 31-aug-2019 / serial #: (b)(4).Udi #: (b)(4).Yes, return date: 04-mar-2020.No, device evaluation anticipated, but not yet begun.Dev rtn to mfr? yes.Mfg date: 02-aug-2018.Labeled for single use? no.(b)(4).Brand name: heartware ventricular assist system  controller ac adapter, medical device: model #: 1430us / catalog #: 1430us / expiration date: 31-jul-2019 / serial #: (b)(4).Udi #: (b)(4).Yes, return date: 04-mar-2020.No, device evaluation anticipated, but not yet begun.Dev rtn to mfr? yes.Mfg date: 10-jul-2018.Labeled for single use? no.(b)(4).Additional information has been requested regarding the outcome of the event, but it was not available at the time of this report.If additional information is received, the event will be updated and a supplemental report will be sent.

Event Description

It was reported that the patient was admitted due to being found down at home with a high priority alarm sounding.The patient lost consciousness while changing power sources, due to a loss of power to the controller and a ventricular assist device (vad) stop.Two batteries were connected to the controller and the vad restarted.It was also reported that the controller, five batteries, and a controller ac adapter exhibited intermittent beeping and power switching.The metal port on side one of the controller seemed a little loose.The patient was discharged then admitted three days later for observation.The controller, batteries and controller ac adapter were exchanged.No further patient complications have been reported as a result of this event.

Event Description

It was further reported that the patient's admission for observation was for monitoring and no further patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for additional information.Newly received information indicated that the patient's admission for observation was for monitoring and no further patient complications have been reported as a result of this event.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.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 controller, four batteries (bat315625, bat317156, bat553596, bat756164) and the controller ac adapter were returned for evaluation.One battery (bat316896) was not returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the returned devices in relation to the reported event.Failure analysis of the returned batteries bat315625, bat317156 and bat756164 revealed that the devices passed visual inspection and functional testing.Of note, it was observed during functional testing that the batteries bat315625 and bat317156 had above 500 charge and discharge cycles.This is an additional finding not related to the reported event and likely due to the batteries reaching the end of their useful life.Failure analysis of the returned battery bat553596 and controller ac adapter revealed that the devices passed functional testing.Visual inspection revealed damage to the outer sheath of the output cable assemblies, exposing internal wires.The observed damage did not affect the functionality of the devices.The observed damage of the output cables are additional findings not related to the reported event and likely due to the handling of the devices.Failure analysis of the returned controller revealed that the device passed functional testing.The controller ports functioned as intended with no observed anomalies.As a result, the reported loose component event was not confirmed.Visual inspection revealed contamination within both power ports and the data port of the controller, likely due to the handling of the device.The contamination observed in the serial port is an additional finding not related to the reported event.Additionally, supplemental testing was performed on the controller, and the test results revealed that the gold-plating of the pins were worn, exposing the base metal.The exposure of the base metal is susceptible to the effects of corrosion.Log file analysis revealed that the controller contained a feature that records whether a power source experienced a communication error or a disconnection within each 15-minute interval.Analysis of the data log files did not reveal any premature power switching events within the analyzed period.Analysis of the data logs revealed several momentary disconnections that did not lead to premature power switching events involving bat315625, bat316896, bat317156, bat756164, and an active adapter.Momentary disconnections will result in an audible tone or "beep".As a result, the reported "beeping" event was confirmed; however, the reported premature power switching event could not be confirmed.Controller log files revealed a controller power up event on 17-feb-2020 at 20:53:11.The data point prior to the loss of power revealed that bat317156 was connected to power port one with 46% relative state of charge (rsoc) and bat756164 was connected to power port two with 24% rsoc.The data point recorded after the loss of power revealed that bat553596 was connected to power port one and bat316896 was connected to power port two.No anomalies were observed leading up to the loss of power.The controller was without power for 39 seconds.Loss of power to the controller will trigger a continuous audible alarm, which corresponds with the reported ¿high priority alarm sounding¿.As a result, the reported loss of power event was confirmed.A power source lubrication procedure was performed on bat316896, bat317156 and bat553596 on (b(6) 2018.A power source lubrication procedure was performed on bat756164 on (b)(6) 2018.There is no evidence a lubrication procedure was performed on (b)(6) 2018 or the controller ac adapter.The most likely root cause of the reported "beeping" prior to lubrication can be attributed to contamination within the power ports and/or momentary disconnections between the controller and batteries.The most likely root cause of the reported "beeping" after lubrication can be attributed to contamination within the power ports and/or corrosion of the controller-port/power-source pins.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.An internal investigation evaluated momentary disconnections prior to lubrication servicing.Additional products: d4: serial #: (b)(4) h3: yes h6: fda method code(s): 10, 4112 h6: fda results code(s): 213, 3213 h6: fda conclusion code(s): 12, 133 d4: serial #: (b)(4) h3: yes h6: fda method code(s): 4112, 4114 h6: fda results code(s): 3213 h6: fda conclusion code(s): 4307 d4: serial #: bat317156 h3: yes h6: fda method code(s): 10, 4112 h6: fda results code(s): 213, 3213 h6: fda conclusion code(s): 133, 4307 d4: serial #: bat553596 h3: yes h6: fda method code(s): 10, 4112 h6: fda results code(s): 180 h6: fda conclusion code(s): 19 d4: serial #: bat756164 h3: yes h6: fda method code(s): 10, 4112 h6: fda results code(s): 3213 h6: fda conclusion code(s): 4307 d4: serial #: cac211746 h3: yes h6: fda method code(s): 10, 4112 h6: fda results code(s): 180, 3213 h6: fda conclusion code(s): 12, 19 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.

Manufacturer Narrative

A supplemental report is being submitted for a correction.Corrected fields: h1 type of report: updated to serious injury additional codes: imf code was updated to f08 this regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) due to an fda audit observation.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 patient was admitted due to being found down at home with a high priority alarm sounding.The patient was admitted for monitoring.The patient lost consciousness while changing power sources, due to a loss of power to the controller and a ventricular assist device (vad) stop.Two batteries were connected to the controller and the vad restarted.It was also reported that the controller, five batteries, and a controller ac adapter exhibited intermittent beeping and power switching.The metal port on side one of the controller seemed a little loose.The patient was discharged then admitted three days later for observation.The controller, batteries and controller ac adapter were exchanged.No further patient complications have been reported as a result of this event.

• 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: 9813028
• MDR Text Key: 240116027
• Report Number: 3007042319-2020-01704
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000420
• UDI-Public: 00888707000420
• 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: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1903-2018
• Patient Sequence Number: 1
• Treatment: 1103 VAD.; 1103 VAD
• Patient Outcome(s): Hospitalization
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 114 KG