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); Use of Device Problem (1670)

Patient Problems Heart Failure/Congestive Heart Failure (4446); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: heartware ventricular assist system ¿ controller 2.0, model #: 1420 / catalog #: 1420 / expiration date: 30-nov-2019 / serial #: (b)(4), udi #: (b)(4).Device manufacture date: no.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Mfg date: 06-nov-2018.Labeled for single use: no.(b)(4).Heartware ventricular assist system ¿ controller 2.0, model #: 1420 / catalog #: 1420 / expiration date: 30-nov-2019 / serial #: (b)(4), udi #: (b)(4).Device manufacture date: no.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Mfg date: 16-nov-2018.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 patient was admitted to the intensive care unit (icu) due to experiencing worsening heart failure associated with a ventricular assist device (vad) stop following a mistaken disconnection of both power sources from the primary controller.It was also reported that the primary controller exhibited a 'vad stopped-change controller' alarm, the primary controller was exchanged with the backup controller, the alarm continued despite the controller exchange and the vad was not running.An echocardiogram was performed and the patient was heparinized.The following day, the vad was exchanged and the patient stabilized.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted to provide a status for the controllers and also to note that the pump has been returned.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

The controllers remain in use.

Manufacturer Narrative

A supplemental report is being submitted for device evaluation.Product event summary: the ventricular assist device (vad) was returned for evaluation.Two (2) controllers 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.Log file analysis revealed that the first controller was originally in use at the time of the reported event.Review of the log files associated with the first controller revealed a controller power up event on (b)(6) 2020 at 11:10:45.The data point 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 a battery was connected to power port two (2) with 35% rsoc.The data point recorded after the loss of power revealed that (b)(6) was connected to power port one (1) and another battery was connected to power port two (2).The controller was without power for 17 seconds.A vad stopped alarm was subsequently logged at 11:11:12 due to a failure of the pump to restart after several attempts.A vad disconnect alarm was then logged at 11:21:17, indicating a physical disconnection of the driveline from the controller, likely during troubleshooting and/or the reported controller exchange.An additional controller power up event and vad stopped alarm due to a failure of the pump to restart were logged at 11:22:37 and 11:23:03, respectively, likely during troubleshooting.As a result, the reported controller loss of power and vad stopped alarm events were confirmed.Log files associated with the second controller were not available for analysis.Therefore, the reported continued alarming following the controller exchange could not be confirmed.A review of the pump's manufacturing documentation confirmed that the associated device met all requirements for release.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 rear housing disc curvature and front housing disc curvature were 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, and, based on the null impact on the wet test power consumption, this deviation is not expected to impact pump performance.Based on the available information, the most likely root cause of the controller loss of power can be attributed to the reported disconnection of both power sources from the controller, as described in the event details.The most likely root cause of the vad stopped alarms can be attributed to a failure of the pump to restart after several attempts.The vad is part of an internal investigation evaluating pump failures to restart.Additional products: d4: serial or lot#: (b)(6); h3: yes; h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d10, d11; d4: serial or lot#: (b)(6); h6: fda method code(s): b17 h6: fda results code(s): c20 h6: fda conclusion code(s): d14 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.

Manufacturer Narrative

A supplemental report is being submitted for correction.Product event summary: 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.Additional products: d4: serial#: (b)(4); h6: patient ime code(s): e2402 h6: imf code(s): f08; d4: serial#: (b)(6); h6: patient ime code(s): e2402 h6: imf code(s): f08 this regulatory report is being submitted as part of a retrospective review and remediation 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.

Manufacturer Narrative

A supplemental correction is being submitted for inclusion of this event as being in-scope for recall with z-0946-2021.This event was submitted historically and has been deemed in-scope for the field corrective action.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 avenue; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 11004081
• MDR Text Key: 243334210
• Report Number: 3007042319-2020-07843
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2020
• Device Model Number: 1104
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2018
• 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: 37 YR
• Patient Sex: Female
• Patient Weight: 64 KG