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

Model Number 1104

Device Problem Failure to Pump (1502)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2021

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-2018 / serial or lot#: con316225.Udi #: (b)(4).Device evaluated: no.No, device evaluation anticipated, but not yet begun.Mfg date: 30-nov-2017 h5: no (b)(4).Heartware ventricular assist system ¿ controller 2.0.Model #: 1420 / catalog #: 1420 / expiration date: 30-nov-2018 / serial or lot#: con316337 udi #: (b)(4).Device evaluated: no.No, device evaluation anticipated, but not yet begun.Mfg date: 30-nov-2017 h5: no (b)(4).Heartware ventricular assist system ¿ controller 2.0.Model #: 1420 / catalog #: 1420 / expiration date: 31-aug-2021 / serial or lot#: con413180 udi #: (b)(4).Device evaluated: no.No, device evaluation anticipated, but not yet begun.Mfg date: 30-nov-2017 h5: no (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that, after a prophylactic controller exchange, the ventricular assist device (vad) would not restart.After forty five minutes of attempts with different controllers, the vad did not restart.The vad is off and remains in the patient.The original controller was exchanged and the other controllers remain with the patient.No 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 indicates that the patient received a heart transplant.Additional information has been requested regarding the date of the transplant, 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.Additional products: controller 2.0 (b)(6).H6: imf code(s): f08, f1903.Controller 2.0 (b)(6).H6: imf code(s): f08, f1903.Controller 2.0 (b)(6).H6: imf code(s): f08, f1903.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.

Event Description

It was further reported that the patient received a heart transplant.

Manufacturer Narrative

Corrections: d6b, e1, h4, additional codes, h10 additional products a supplemental report is being submitted for corrections and device evaluation.D6b explanted date corrected to (b)(6) 2020.E1 fax number corrected to (b)(6) and phone number corrected to (b)(6).H4 device manufacture date corrected from 31-mar-2018 to 13-mar-2018.Additional codes corrected f26 to f1203.H10 additional product (b)(6), h4 device manufacture date corrected from 30-nov-2017 to 10-nov-2017 and h6 imf codes corrected f26 to f1203, additional product (b)(6), h4 device manufacture date corrected from 30-nov-2017 to 14-nov-2017 and h6 imf codes corrected f26 to f1203, and additional product (b)(6) h6 imf codes corrected f26 to f1203.Product event summary: the ventricular assist device (vad) ((b)(6)) and three controllers ((b)(6)) were not returned for evaluation.Log file analysis revealed that (b)(6) was the patient's primary controller, initially in use leading up to the reported event.A vad disconnect alarm was recorded on (b)(6) 2021 at 14:14:27 indicating a physical disconnection of the driveline from the controller, which corresponds with the reported prophylactic controller exchange.A controller power-up event associated with (b)(6) was then logged at 14:16:17, followed by a vad stopped alarm at 14:16:38 indicating that the pump failed to restart after multiple attempts.Review of the log files associated with (b)(6) revealed a controller power-up event at 13:21:25, after which the date and time, patient id, pump id, and pump speed were set, indicating that the controller was being programmed for use following the controller exchange.A second controller power-up event was logged at 13:26:24, with a vad disconnect alarm logged at 13:26:32, indicating that the driveline was not connected to the controller at the time of the power-up event.The vad disconnect alarm cleared at 13:26:39, indicating that the driveline was connected, after which a vad stopped alarm was logged at 13:27:10 due to the pump failing to restart after multiple attempts.Several additional controller power-up events and vad stopped alarms due to failures of the pump to restart were logged on (b)(6) between 13:27:29 and 13:29:55, likely during troubleshooting.Of note, based on the log files, the vad stopped alarms recorded on con413180 were recorded at a time during which (b)(6) was still in use, indicating that there was likely an incorrect time setting on the primary controller.Review of the log files associated with (b)(6) revealed that a controller power-up event was logged at 13:36:35; prior to the power-up event, the controller last had power on (b)(6) 2021.A vad disconnect alarm was then logged at 13:36:39, indicating that the driveline was not connected to this controller and that this controller was not in use with the pump during the reported event.As a result, the reported event was confirmed.(b)(6) is not in scope 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 several attempts.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 h4: mfg date: 10-nov-2017 h6: imf code(s): f1203 h6: img code(s): g04035 h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d10 d4: serial #: (b)(6), h3: yes h4: mfg date: 14-nov-2017 h6: imf code(s): f1203 h6: img code(s): g04035 h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 d4: serial #: con413180 h3: yes h6: imf code(s): f1203 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

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 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: 11453428
• MDR Text Key: 247503628
• Report Number: 3007042319-2021-01894
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2020
• Device Model Number: 1104
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2018
• 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