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

Model Number 1103

Device Problems Failure to Pump (1502); Pumping Stopped (1503); Power Problem (3010)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/23/2021

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Heartware ventricular assist system ¿ controller 2.0, model #: 1420 / catalog #: 1420 / expiration date: 31-aug-2019 / serial #: (b)(4), udi #: (b)(4).Device available for evaluation: yes.03-mar-2021.Device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun.Device manufacture date: 28-aug-2018.Labeled for single use: yes, 03-mar-2021.(b)(4).Heartware ventricular assist system ¿ controller 2.0, model #: 1420 / catalog #: 1420 / expiration date: 31-aug-2019 / serial #: (b)(4), udi #: (b)(4).Device available for evaluation: no.Device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun.Device returned to manufacturer?: yes.Manufacturing date: 28-aug-2018.Labeled for single use: yes, 03-mar-2021.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.Manufacturing date: 17-nov-2020.Labeled for single use: no.

Event Description

It was reported that the patient was admitted for an elective controller exchange.The ventricular assist device (vad) failed to restart after the controller exchange, resulting in several vad stopped alarms.The new controller was power cycled and changed to the patient¿s previous backup controller and then switched to another controller in an effort to restart the vad with no success.All three controllers also exhibited unexpected losses of power.The vad was exchanged and two controllers were replaced.One controller remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for device evaluation product event summary: the ventricular assist device (vad) and two controllers (con402055, con402044) were returned for evaluation.One controller (con414441) was 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.A review of the pump's manufacturing documentation confirmed that the associated device met all requirements for release.Failure analysis of con402044 revealed that the device passed visual examination and functional testing.Failure analysis of con402055 revealed that the device passed functional testing; however, visual inspection revealed contamination in both power ports of the controller.This is an additional observation not related to the reported event, likely attributed to the handing of the device.Failure analysis of the returned vad revealed that the device passed visual examination.Functional testing of the device revealed a power shift condition.Additionally, dimensional verification revealed that the front housing disc curvature was found to be deviating from specifications.Given that the pump met specifications prior to release, these deviations were likely a result of the clinical challenge to the pump.Further analysis revealed outer shroud contact that created more friction at the housing to impeller interface; this increase in friction was investigated during the capa pr00502194 investigation.Internal pathological report revealed no evidence of thrombus within the device.Log file analysis revealed that con402055 was the primary controller in use leading up to the reported event date.A vad disconnect alarm was logged on (b)(6) 2021 at 10:33:46, indicating a physical disconnection of the driveline from the controller, which correlates with the reported controller exchange.A controller power up event was recorded at 10:39:39, which was followed by a vad stopped alarm at 10:40:38 due to a failure of the pump to restart after multiple attempts.This was followed by several additional controller power up events, another vad stopped alarm due to a failure of the pump to restart, and a vad disconnect alarm due to a disconnection of the driveline from the controller, which were likely recorded during troubleshooting.Additionally, analysis of the alarm log file revealed that a power disconnect alarm was logged.During the power disconnect alarm, a safety alert word (saw) value was recorded indicating an overcurrent alert.The event log recorded a high power consumption during the motor starts, which required more current from the battery.The battery was most likely physically disconnected by the patient shortly after, causing the controller to log this event as a power disconnect alarm.Review of the controller log files associated with con402044 revealed a controller power up event on (b)(6) 2021 at 09:33:29.Review of the event log file revealed that, prior to the power up event, the controller last had power on (b)(6) 2020, indicating that the power up event occurred during a controller exchange.A vad stopped alarm was then logged at 09:34:25 due to a failure of the pump to restart after multiple attempts.This was followed by several additional controller power up events, likely during troubleshooting.Review of the controller log files associated with con414441 revealed a controller power up event on (b)(6) 2021 at 08:00:22, followed by the initial setup of the controller, including programming of the time and date, speed, hematocrit, and patient id.A vad stopped alarm was then logged at 09:37:40 due to a failure of the pump to restart after multiple events.This was followed by additional controller power up events and vad stopped alarms due to failures of the pump to restart, likely recorded during troubleshooting.As a result, t he reported event was confirmed.Of note, based on the log files, the events and alarms recorded on con402044 and con414441 were recorded while con402055 was still in use, indicating that there was likely an incorrect time setting on one or more of the controllers.(b)(6) is part of fca cvg-21-q3-21.The most likely root cause of the vad stopped alarms can be attributed to failures of the pump to restart after multiple attempts.Capa pr00502194 is investigating pump failures to restart.The most likely root cause f the reported controller losses of power can be attributed to controller exchanges and/or troubleshooting of the vad stopped alarms.Additional products: con402044 d10: yes, return date: 03-mar-2021 h3: yes dev rtn to mfr? yes h6: img code(s): g04073 h6: fda method code(s): b15, b01 h6: fda results code(s): c19 h6: fda conclusion code(s): d10 con402055 d10: yes, return date: 03-mar-2021 h3: yes dev rtn to mfr? yes h6: img code(s): g04070 h6: fda method code(s): b15, b01 h6: fda results code(s): c15, c19 h6: fda conclusion code(s): d10, d11 con414441 d10: yes, return date: 19-jul-2021 h3: yes dev rtn to mfr? yes h6: img code(s): g04035 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.

Manufacturer Narrative

This supplemental is based solely on the receipt of a medwatch report.Section f has been updated to reflect that report.Medwatch database report number: mw5099649.The patient weight, ethnicity and relevant history have been updated.F1 user facility.F2 uf/importer report number: mw5099649.F3 user facility name/address: (b)(6).F4 contact person: (b)(6).F5 phone number: (b)(6).F6 date user facility became aware of the event: 23-feb-2021.F7 type of report: serious injury.F8 date of this report:23-feb-2021.F9 approximate age of device: unknown.F10 event problem codes.F11 report sent to fda: yes, 04-mar-2021.F12 location where event occurred: unknown.F13 report sent to manufacturer: unknown.F14 manufacturer name and address mfr.Name: medtronic, plc addl: 14400 nw 60th ave city: miami lakes state: fl zip: 33014.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: 11414393
• MDR Text Key: 243147170
• Report Number: 3007042319-2021-01809
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2018
• 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
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American