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

Model Number 1104

Device Problems Vibration (1674); Pumping Problem (3016); Noise, Audible (3273)

Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2022

Event Type  Injury  

Event Description

It was reported that the ventricular assist device (vad) exhibited high power consumption spikes along with high watt alarms.The vad remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional information has been requested regarding the implant date of the ventricular assist device (vad) and patient information 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.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A supplemental report is being submitted as additional information has being received for this event.Updated section: a2 age at the event a4 weight in lbs b7 relevant history 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 event details, patient sex, and vad implanted date.H1 type of reportable event was updated from malfunction to serious injury.B1 was updated from product problem to adverse event & product problem.B2 outcome attributed to adverse event was updated with life threatening.H6 codes were also updated.Additional information has been requested regarding further event details, but it was not available at the time of this report.If a dditional information is received, the event will be updated and a supplemental report will be sent.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 a third harmonic was present, and pump thrombosis was suspected.It was confirmed that the pump sound was unusual.It was noted that no lysis was performed, and the volume status was managed.No further patient complications have been reported as a result of this event.

Event Description

It was further reported by the patient that there was a sound and/or vibration from the vad.

Manufacturer Narrative

A supplemental report is being submitted for additional event information and a correction.Event date was corrected from 02-jun-2022 to 23-may-2022.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 as additional information has being received for this event.Updated section: b5 desc evt problem 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 volume status was corrected not managed.

Manufacturer Narrative

A supplemental report is being submitted for investigation summary.Product event summary: the ventricular assist device (vad) (b)(6) was not returned for evaluation.The reported high power event was confirmed via review of the controller file files which revealed several instances of power consumption above the normal operating range throughout the analyzed period, including a sharp sustained increase in power consumption and estimated flows beginning on (b)(6) 2022 leading to parameters above the normal operating range; 88 high watt alarms were logged since (b)(6) 2022.An audio file provided by the site revealed an abnormal sound from the pump during use, thus confirming the "unusual pump sound" event.Information reviewed from the site indicated that pump thrombosis was suspected, no lysis was performed, and the volume status was corrected not managed.Based on the available information, the device may have caused or contributed to the reported event.Based on historical review of similar high power events, the most likely root cause of the high power event can be attributed to external factors such as thrombus formation/ingestion.Based on the risk documentation, the reported "unusual pump sound" event may be attributed to multiple factors including but not limited to thrombus within the device leading to impeller imbalance or the placement of the pump which allows contact with fixed or rigid anatomical structure.Per the instructions for use, device thrombus is a known potential complication associated with the implantation of an vad.There was no evidence that the patient had a history of thrombus events.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.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 additional event details.The b5.Desc evt problem, the outcome attributed to adverse event the explant date and the annex f code has been updated.Investigation of this event has been reopened to evaluate the additional information and 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 vad has been explanted because the patient was transplanted.

Manufacturer Narrative

A supplemental report is being submitted for device evaluation and an update to the product event summary.Product event summary: (b)(6) was returned for evaluation.Review of the manufacturing records confirmed that the associated pump met all requirements prior to release.The reported high-power event was confirmed via review of the controller log files which revealed several instances of power consumption above the normal operating range throughout the analyzed period, including two (2) sudden spikes in power consumption logged on 16-jun-2022 and 01-jul-2022 and a sharp sustained increase in power consumption and estimated flows beginning on 12-jul-2022 to parameters above the normal operating range, followed by a gradual return to baseline parameters.Several additional spikes in power consumption to parameters above the normal operating range were logged starting on 08-aug-2022.One hundred and seventy-five (175) high watt alarms were logged since 30-may-2022.An audio file provided by the site revealed an abnormal sound from the pump during use, thus confirming the "unusual pump sound" event.Failure analysis of the returned pump revealed that the device passed functional testing.Visual examination revealed abrasions on the lower housing ceramic surface and on the inferior surface of the impeller.Further visual inspection revealed a crack along the center post cap welding.Dimensional verific ation revealed that back preload, spring rate, front housing disc curvature and rear housing disc curvature measurements were found to be deviating from release specifications.Since the spring rate measurement was deviating from specifications, the toggle free test also failed as a result.Capa pr00578223 was opened to investigate post-explant issues found during failure analysis of returned pumps.Internal pathological report revealed no evidence of thrombus within the device.Information received from the site indicated that pump thrombosis was suspected, no lysis was performed, and the volume status was corrected not managed.It was further reported that the vad was explanted because the patient was transplanted.Based on the investigation conducted, the most likely root cause of the reported high power, pump excessive vibration, "unusual pump sound" and friction marks on the lower housing ceramic surface and on the inferior surface of the impeller events may be attributed to the local demagnetization of the inner bearing sub assembly.It is likely that the observed crack along the center post cap welding allowed fluid/moisture ingress in the center post chamber, compromising the magnetic field of the inner bearing magnets.The local demagnetization compromised the axial forces between the impeller and the center post, thus leading to sporadic friction between the two components.(b)(6) is in scope of fa1243, which was i nitiated for pumps with a potential manufacturing issue that may result in demagnetization.Capa pr00510718 is investigating demagnetization of the inner bearing assembly.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.

• 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: 14774562
• MDR Text Key: 301762659
• Report Number: 3007042319-2022-05472
• 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,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2020
• Device Model Number: 1104
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2018
• 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-1207-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 84 KG