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

Model Number MCS1705PU

Device Problems Contamination (1120); Electrical /Electronic Property Problem (1198); Pumping Stopped (1503); Material Integrity Problem (2978)

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

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested regarding the details of the event, 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: brand name: heartware ventricular assist system  controller 2.0 , medical device: model #: 1420 / catalog #: 1420 / expiration date: 31-dec-2021 / serial or lot#: (b)(4), udi #: (b)(4).Device available for evaluation? no.Device evaluated by manufacturer? no, device evaluation anticipated, but not yet begun.Device mfg date: 31-dec-2020.(b)(4).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 during the ventricular assist device (vad) implant procedure adhesive got on the metal portion of the driveline that plugs into the controller.It was also noted that the patient was in post-operative for two hours when the vad started having electrical faults.The vad stopped working and the controller was exchanged.The vad remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for patient and initial reporter information.Also, the manufacturer's notification date was updated to 13-apr-2021.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 device analysis.Product event summary: one (1) controller ((b)(6)) was returned for evaluation.The ventricular assist device (vad) ((b)(6)) 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.Failure analysis of the returned controller revealed that the device passed visual inspection and functional testing.Visual inspection did not reveal any signs of contamination within the driveline connector.Supplemental testing revealed that the controller¿s driveline connector functioned as intended with no anomalies observed.Review of the controller log files associated with (b)(6) revealed multiple vad disconnect alarms, electrical fault alarms, and vad stopped alarms logged on 13-apr-2021.A vad disconnect alarm was logged at 11:45:44; review of the data log file revealed that the first data point with the pump connected was logged at 11:53:09 on 13-apr-2021, indicating that the vad disconnect alarm was likely due to the controller being powered up without the driveline cable connected.An additional vad disconnect alarm was logged at 15:02:01, indicating a physical disconnection of the driveline from the controller.Four (4) electrical fault alarms were then logged between 15:02:20 and 16:11:28, one (1) of which was due to the rear stator not being connected, one (1) of which was due to an open phase on the front stator, and two (2) of which were due to an open phase on the rear stator, resulting in single stator operation.An additional vad disconnect alarm was logged at 15:02:45, indicating a physical disconnection of the driveline from the controller, followed by two (2) vad stopped alarms at 16:19:11 and 16:28:11 due to open phases on both stators.Four (4) additional electrical fault alarms were then logged due to open phases on the front stator and one (1) additional electrical fault alarm was logged due to an open phase on the rear stator.Another vad stopped alarm due to open phases on both stators and an additional electrical fault alarm due to the rear stator not being connected were then logged.A vad stopped alarm was then logged at 16:49:58, indicating that the pump failed to restart after several attempts.An additional vad disconnect alarm was logged at 16:51:27, likely due to troubleshooting during the reported controller exchange.Review of the controller log files associated with (b)(6) revealed a successful motor start event logged at 16:53:36, indicating that the pump was able to successfully restart following the reported controller exchange.Of note, visual evidence provided by the site revealed evidence of foreign material on the outside of the driveline cable¿s connector.As a result, the reported electrical fault alarms, vad stop, and foreign material events were confirmed.There was no evidence of contamination within the driveline connector which may have contributed to the reported electrical fault alarms or vad stop alarms.Based on the available information, the most likely root cause of the foreign material on the driveline connector can be attributed to the handling of the device during the implant procedure.Based on risk documentation and the available information, a possible root cause of the electrical fault alarms and vad stopped alarms due to open phases can be attributed, but not limited, to a marginal driveline connection and/or contamination by foreign material of the driveline connector.The most likely root cause of the remaining vad stopped alarm can be attributed to a failure of the pump to restart after several attempts.(b)(6) was not in scope of fca (b)(6)-21-(b)(6)-21.Capa pr00532915 is investigating pump failures to restart outside the subpopulation of fca cvg-21-q3-21.Additional products: d4: serial or lot#: (b)(6) d9: yes, return date: 03-may-2021 h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b15 h6: fda results code(s): c04, c19 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 report is being submitted for an additional event device code.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.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: 11699774
• MDR Text Key: 247718316
• Report Number: 3007042319-2021-03280
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707005364
• UDI-Public: 00888707005364
• 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: 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: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2022
• Device Model Number: MCS1705PU
• Device Catalogue Number: MCS1705PU
• 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: 10/22/2020
• 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 Age: 72 YR
• Patient Sex: Female
• Patient Weight: 72 KG