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 Dyspnea (1816); Thrombosis/Thrombus (4440)

Event Date 11/23/2021

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested regarding the intervention provided and log files, 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.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 patient experienced shortness of breath and that the ventricular assist device (vad) exhibited a sudden reduction in power consumption and estimated flow rate.A vad thrombus was suspected and the patient was urgently hospitalized.Auscultation was performed and found that the vad exhibited a low frequency sound and excessive vibration.The patient had elevated lactate dehydrogenase (ldh).The patient underwent an emergency right heart catheterization study and a transesophageal echocardiogram (tee).The vad remains in use.No patient complications have been reported as a result of this event.

Event Description

It was further reported that the abnormal noise suddenly disappeared approximately ten days later, the estimated flow rate recovered, and the patient was stable.The echocardiography was repeated and the once visible agitated object was now gone.It was also further reported that the patient international normalized ratio (inr) was greater than 3.0 and heparin was administered.

Manufacturer Narrative

A supplemental is being submitted for an update to b5.Desc evt problem, h.3.Device evaluated no eval explain code and imf 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.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: the ventricular assist device (vad) (b)(6) was not returned for evaluation.Review of the controller log files which revealed a sudden decrease in power consumption and estimated flows on (b)(6) 2021 leading to parameters below the normal operating range, followed by an increase in power consumption and estimated flows parameters.However, no alarms were logged within the analyzed period.Information received from the site indicated that, in addition to the low power/flow event, the patient experienced shortness of breath.A vad thrombus was suspected and the patient was urgently hospitalized.Auscultation was performed and found that the vad exhibited a low frequency sound and excessive vibration.The patient had elevated lactate dehydrogenase (ldh).The patient underwent an emergency right heart catheterization study and a transesophageal echocardiogram (tee).It was further reported that the abnormal noise suddenly disappeared approximately ten days later, the estimated flow rate recovered, and the patient was stable.The echocardiography was repeated and the once visible agitated object was now gone.It was also further reported that the patient international normalized ratio (inr) was greater than 3.0 and heparin was administered, which corresponds with the increase in power and flows observed in the logs.As a result, the reported low power and low flow events were confirmed.The reported "a low frequency sound and excessive vibration" could not be confirmed due to insufficient evidence.Based on the available information, the device may have caused or contributed to the reported event.Based on the available information, the most likely root cause of the low flow and low power event can be attributed to external factors such as thrombus at the inflow cannula/outflow graft.Based on the risk documentation and the available information, the most likely root cause of the reported "a low frequency sound and excessive vibration" event may be attributed to, but not limited to, thrombus within the device leading to impeller imbalance.Per the instructions for use, device thrombus is a known potential complication associated with the implantation of a 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 hi story 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.

• 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: 12912104
• MDR Text Key: 281588658
• Report Number: 3007042319-2021-08236
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• 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: 1104
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 48 YR
• Patient Sex: Male