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

Model Number 1420

Device Problems Failure to Pump (1502); Pumping Stopped (1503); Connection Problem (2900); Material Twisted/Bent (2981); Power Problem (3010); Pumping Problem (3016)

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

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the controller exhibited poor mechanical connection due to bent pins on the data port.The controller was exchanged.No patient complications have been reported as a result of this event.

Event Description

It was further reported that the vad did not restart when the primary controller was exchanged to the backup controller the first time, and was switch back to the primary controller until it was safe to continue the exchange to the back up controller.

Manufacturer Narrative

A supplemental report is being submitted for additional information.The event description has been updated to include that the vad did not restart after the initial primary controller exchange.A device code (fdd) has been added to the vad in h10.Additional products: d4: serial #: (b)(6) h6: device code(s): c63165 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

It was further reported that the backup controller exhibited a loss of power and the ventricular assist device (vad) exhibited below normal power consumption and a vad stop alarm with the loss of power of the controller.The vad and the backup controller remains in use.

Manufacturer Narrative

A supplemental report is being submitted for additional information.Additional products: d1: heartware ventricular assist system ¿ controller d4: model #: 1420 / catalog #: 1420 / expiration date: 30-jun-2020 / serial #: (b)(6) udi #: (b)(4)d9: no h3: no, device evaluation anticipated, but not yet begun h4: mfg date: 02-jun-2020 h5: no h6: patient ime code(s): e2403 h6: imf code(s): f26 h6: fda device code(s): a0708 h6: fda results code(s): c21 h6: fda conclusion code(s): d16 d1: heartware ventricular assist system ¿ pump d4: model #: 1103 / catalog #: 1103 / expiration date: 31-aug-2021 / serial #: hw41227 udi #: (b)(4)d9: no h3: no, device evaluation anticipated, but not yet begun h4: mfg date: 08-aug-2019 h5: yes h6: patient ime code(s): e2403 h6: imf code(s): f26 h6: fda device code(s): a1412, a141204 h6: fda results code(s): c21 h6: fda conclusion code(s): d16 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.

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.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 device evaluation.Product event summary: one controller was returned for evaluation.The pump and one controller were not returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the returned device in relation to the reported event.Failure analysis of the returned controller revealed a bent pin within the serial port.The bent pin did not allow a data cable to properly connect to the controller.During supplemental testing the bent pin was re-aligned and then the controller performed as intended.As a result, the reported bent pin event was confirmed.Log file analysis associated with (b)(6) revealed two vad disconnect alarms were logged on 07-jan-2021 at 14:21:39 and 14:37:16.This alarm is indicative of the driveline not being connected to the controller and is displayed on the monitor as a vad stopped alarm.Log file analysis associated with (b)(6) also revealed three controller power up events logged on 07-jan-2021 between 14:21:32 and 15:22:51 with two associated motor start events at 15:21:04 and 15:22:52.Review of the event log file revealed that, prior to the first power up event, the controller last had power on (b)(6) 2020.Review of the data log file revealed that the controller was not in use prior to the controller power up events; the first data point was logged at 14:22:07 on 07-jan-2021, indicating that the power up events and vad disconnect alarms occurred during a controller exchange.Review of the available data log file associated with (b)(6) revealed only one data point with the pump connected logged on (b)(6) 2021 at 15:23:24; power consumption was below normal operating range.This was followed by a controller power up event without a motor start at 15:28:25, likely due to troubleshooting during the reported controller exchange.As a result, the reported low power, vad stop alarm, loss of power events were confirmed; however, the reported failure to restart event was not confirmed.The most likely root cause of the reported bent pin event can be attributed to a misalignment between the serial port and data cable.Capa pr00384004 was opened to investigate bent/damaged pins with controller 2.0.Based on the available information, the most likely root cause of the vad disconnect alarms observed in the log files may be attributed to the controller powering up without a driveline cable connected.Based on the available information, the most likely root cause of the controller power up event can be attributed to a controller exchange.Based on the risk documentation, possible causes of the reported low power event may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, inappropriate pump rotational speed, and/or poor vad filling.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): d14 d4: serial or lot#: hw41227 h3: yes 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.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 - CONTROLLER 2.0
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 11167070
• MDR Text Key: 228483186
• Report Number: 3007042319-2021-00182
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707006859
• UDI-Public: 00888707006859
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2021
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 01/07/2021; 02/01/2021; 04/02/2021; 04/06/2021
• Supplement Dates FDA Received: 01/22/2021; 02/09/2021; 04/09/2021; 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1336-2021
• Patient Sequence Number: 1
• Treatment: 1103 VAD, 690R28 HEART RING
• Patient Age: 49 YR
• Patient Weight: 89