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

Model Number 1103

Device Problems Electrical /Electronic Property Problem (1198); Pumping Stopped (1503); Connection Problem (2900); Pumping Problem (3016); Device Fell (4014)

Patient Problem Unspecified Nervous System Problem (4426)

Event Date 10/02/2021

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.This information was received from the product surveillance registry mechanical circulatory services therapy base.Additional products brand name: heartware ventricular assist system ¿ controller 2.0, model #: 1650de , catalog #: 1650de, expiration date: (b)(6) 2020, serial or lot#: (b)(4), udi #: (b)(4).Device available for evalution: no.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Mfg date: 10-dec-2019, labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system ¿ controller 2.0, model #: 1650de, catalog #: 1650de, expiration date: 31-may-2021, serial or lot#: (b)(4), udi #: (b)(4).Device available for evaluation: no.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Mfg date: 14-may-2020.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 dropped their primary controller, and at that time the driveline was pulled out of the controller.An alarm sounded, but it is unknown which alarm sounded.The controller was exchanged.The next day the ventricular assist device (vad) exhibited high watt alarms all day.The vad high priority urgent alarm sounded and showed ¿electrical fault¿ simultaneously on the controller then went black.Per the patient¿s son, the patient was then posturing in a decorticate posture and does not remember this happening.It was suspected that the driveline was not put in all the way after the controller exchange and was not seated well, and this caused the electrical fault alarms which were related to the high watt alarms.Because the vad stopped and was not giving any flow, the decision was made to switch the patient back to the primary controller.The vad then started flowing appropriately, and the patient remembers everything after that.The following day the patient was admitted for monitoring.The controller and vad remain in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for a correction, device analysis, and investigation completion.Section h10 additional products d4 model and catalog numbers were corrected to 1420.Product event summary: the ventricular assist device (vad) (b)(6) and two (2) controllers (b)(6) were not returned for evaluation.Log file analysis revealed that (b)(6) was the primary controller, initially in use during the reported event.Review of the controller log files associated with (b)(6) revealed a vad disconnect alarm logged on (b)(6) 2021 at 11:44:42, indicating a physical disconnection of the driveline from the controller, which corresponds with the reported controller drop event resulting in a driveline disconnection.A controller power-up event without an associated motor start event was logged at 11:48:03, likely during the reported controller exchange.Log file analysis revealed that (b)(6) was then in use.Review of the log files associated with (b)(6) revealed a controller power-up event, with an associated motor start event, logged on (b)(6) 2021 at 10:54:37.Review of (b)(6)¿s alarm log file revealed 47 electrical fault alarms, (b)(4) high watt alarms, 2 vad disconnect alarms, and a vad stopped alarm logged on (b)(6)2021.(b)(4) electrical fault alarms were logged between 12:15:53 and 20:07:59, indicating an open phase on the front stator, resulting in the pump running on a single stator (rear stator only).This likely triggered the subsequent high watt alarms, which were logged between 12:15:55 and 20:08:01, due to the increased power consumption required to run on a single stator.A vad disconnect alarm was logged at 20:08:33 due to open phases on both stators, followed by an additional electrical fault alarm at 20:08:38, indicating that the front stator was not connected.A vad stopped alarm was logged at 20:09:45 due to a failure of the pump to restart after several attempts.An additional vad disconnect alarm was then logged at 20:10:33 due to a physical disconnection of the driveline from the controller, likely due to the reported controller exchange.A controller power up event was logged on (b)(6) at 21:01:20, with a subsequent vad disconnect alarm logged at 21:01:29, indicating that the controller was powered up without the driveline cable connected.A successful motor start event was logged on (b)(6) 2021 at 21:01:45.Log file analysis did not reveal any loss of power events which were not involved with a controller exchange within the analyzed period.Of note, based on the log files, the initial controller power-up and motor start events on (b)(6) were recorded while (b)(6) was still in use, ind icating that there was likely an incorrect time setting on one of the controllers.Vad disconnect and vad stopped alarms are high priority alarms which cause the alarm indicator on the controller's front panel to flash red.It is likely the pump stoppage associated with the vad disconnect and vad stopped alarms corresponds with the reported "no flow" event.As a result, the reported drop event associated with a vad disconnect alarm, electrical fault alarms, high watt alarms, "high priority alarm," and "no flow" events were confirmed.The reported driveline cable poor mechanical connection and "controller went blank" events could not be confirmed.Based on the available information, the most likely root cause of the reported drop event can be attributed to the handling of the device.The most likely root cause of the initial vad disconnect alarm can be attributed to a physical disconnection of the driveline from the controller due to a controller drop, as described in the event details.Based on risk documentation and the available information, a possible root cause of the electrical fault alarms, high power, and the vad disconnect alarm due to open phases on both stators can be attributed, but not limited, to contamination by foreign material of the driveline connector and/or a marginal driveline connection.The reported driveline poor mechanical connection event can most likely be attributed to a marginal connection between the driveline and controller.The most likely root cause of the remaining vad disconnect alarms can be attributed to physical disconnections of the driveline from the controller during troubleshooting.The most likely root cause of the vad stopped alarm can be attributed to failure of the pump to restart after several attempts.(b)(6)was not in scope of fca cvg-21-q3-21.Capa pr00532915 is investigating pump failures to restart outside the subpopulation of fca cvg-21-q3-21.Additional products: controller 2.0 (b)(6).D4: model #: 1420 / catalog #: 1420 h3: yes.H6: fda method code(s): b15, b17 h6: fda results code(s): c23.H6: fda conclusion code(s): d11 controller 2.0 (b)(6).D4: model #: 1420 / catalog #: 1420 h3: yes.H6: img code(s): g04034 h6: fda method code(s): b15, b17.H6: fda results code(s): c19, c04.H6: fda conclusion code(s): d10, d15 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/DRIVELINE
• 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: 12606236
• MDR Text Key: 277192744
• Report Number: 3007042319-2021-06563
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• 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: 1103
• Device Catalogue Number: 1103
• 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: 11/02/2018
• 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): Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female