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

Model Number MCS1705PU

Device Problem Pumping Problem (3016)

Patient Problems Aspiration/Inhalation (1725); Fever (1858); Intracranial Hemorrhage (1891); High Blood Pressure/ Hypertension (1908); Hypoxia (1918); Pleural Effusion (2010); Sepsis (2067); Tachycardia (2095); Ventricular Fibrillation (2130); Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Date 02/28/2022

Event Type  Death  

Event Description

It was reported that the ventricular assist device (vad) patient presented to the emergency room (ed) with admission for septic picture.The patient had fever, increased shortness of breath, increased oxygen requirements and leukocytosis.Upon the admission, a blood cultures was taken, and after three days later, the result came positive for streptococcus salivarius then the patient started on intravenous (iv) antibiotic therapy.Of note, patient had left/right pleural effusions drained, suspected pulmonary valvular vegetation, and right extremity knee/ ankle aspiration procedure performed in association to admission.Three days later, the patient went into ventricular tachycardia (vt) storm episode with multiple implantable cardioverter defibrillator (icd) shocks for sustained ventricular tachycardia and ventricular fibrillation and multiple instances of reverting back into arrhythmias.The patient was eventually cardioverted and started on glucose tolerance test (gtt) anti-arrhythmic iv therapies.It was also noted that the vad exhibited low flows during the event.No further 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.This information was received from the product surveillance registration mechanical circulatory support therapy base.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A supplemental report is being submitted for investigation completion.Product event summary: the ventricular assist device (vad) was not returned for evaluation.The reported low flow event was not confirmed via review of the controller log files since log files were not available for analysis.Review of the sterility certificate confirmed that the associated device met all requirements for release.Information provided indicated that the patient presented to the emergency room (ed) with admission for septic picture.The patient had fever, increased shortness of breath, increased oxygen requirements and leukocytosis.Upon the admission, a blood cultures was taken, and after three days later, the result came positive for streptococcus salivarius, then the patient was started on intravenous (iv) antibiotic therapy.Of note, patient had left/right pleural effusions drained, suspected pulmonary valvular vegetation, and right extremity knee/ ankle aspiration procedure performed in association to admission.Three days later, the patient went into ventricular tachycardia (vt) storm episode with multiple implantable cardioverter defibrillator (icd) shocks for sustained ventricular tachycardia and ventricular fibrillation and multiple instances of reverting back into arrhythmias.The patient was eventually cardioverted and started on glucose tolerance test (gtt) anti-arrhythmic iv therapies.It was also noted that the vad exhibited low flows during the event.No further patient complications have been reported as a result of this event.It was further reported that the patient experienced respiratory failure.Despite continuous positive airway pressure (cpap) the patient experienced hypoxia, was intubated and started on nasal canula therapy.It was further reported that the patient was found to be non-responsive the next day.Brain attack was called with subsequent head computerized tomography (ct).Imaging showed large left occipitoparietal and temporal parenchymal hemorrhage with extensive regional vasogenic edema and mass effect.There was approximately 23 mm of left-to-right mid-line shift with both subfalcine and descending transtentorial herniation.Also, there was extensive mass effect on the mid-brain and superior pons.The patient was transitioned to comfort measures and subsequently expired.It was further reported that the source of bacteremia was unknown.Based on the available information, the device may have caused or contributed to the reported event.Based on the risk documentation, possible causes of the reported low flow event may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, poor vad filling, and/or inappropriate pump rotational speed.Per the instructions for use, cardiac arrhythmia, neurologic dysfunction, hypertension and infection are known potential complications associated with the implantation of a vad.Based on a review of past adverse events, it was noted that the patient had a history of infection 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 if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A supplemental report is being submitted for additional information.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 further reported that the source of bacteremia was unknown.

Manufacturer Narrative

A supplemental report is being submitted for additional information received.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 patient experienced respiratory failure.Despite continuous positive airway pressure (cpap) the patient had hypoxia, was intubated and started on nasal canula therapy.

Manufacturer Narrative

A supplemental report is being submitted for an update / correction to: updated sections: b2.Outcome attributed to adverse event, b5.Desc evt problem, h1.Type of reportable event, h6.Patient codes (ime/annex e) ,additional codes: imf (annex f) health impact corrected section: d4.Model / catalog# from 1103 to mcs1705pu.Death was previously reported in fda report number: 3007042319-2022-04480.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.

Event Description

It was further reported that the patient was found to be non-responsive the next day.Brain attack was called with subsequent head computerized tomography (ct).Imaging showed large left occipitoparietal and temporal parenchymal hemorrhage with extensive regional vasogenic edema and mass effect.There was approximately 23 mm of left-to-right midline shift with both subfalcine and descending transtentorial herniation.Also, there was extensive mass effect on the midbrain and superior pons.The patient was transitioned to comfort measures and subsequently expired.

Event Description

It was further reported that implantable pulse generator (ipg) and cardiac resynchronization therapy was also performed.It was also reported that anesthetic medications was administered.-.

Manufacturer Narrative

A supplemental report is being submitted for an update and correction to b5.Desc evt problem.Correction: added implantable pulse generator (ipg) and cardiac resynchronization therapy updated: anesthetic medication administered.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 investigation completion.Product event summary: the ventricular assist device (vad) was not returned for evaluation.The reported low flow event was not confirmed via review of the controller log files since log files were not available for analysis.Review of the sterility certificate confirmed that the associated device met all requirements for release.Information provided indicated that the patient presented to the emergency room (ed) with admission for septic picture.The patient had fever, increased shortness of breath, increased oxygen requirements and leukocytosis.Upon the admission, a blood cultures was taken, and after three days later, the result came positive for streptococcus salivarius, then the patient was started on intravenous (iv) antibiotic therapy.Of note, patient had left/right pleural effusions drained, suspected pulmonary valvular vegetation, and right extremity knee/ ankle aspiration procedure performed in association to admission.Three days later, the patient went into ventricular tachycardia (vt) storm episode with multiple implantable cardioverter defibrillator (icd) shocks for sustained ventricular tachycardia and ventricular fibrillation and multiple instances of reverting back into arrhythmias.The patient was eventually cardioverted and started on glucose tolerance test (gtt) anti-arrhythmic iv therapies.It was also noted that the vad exhibited low flows during the event.No further patient complications have been reported as a result of this event.It was further reported that the patient experienced respiratory failure.Despite continuous positive airway pressure (cpap) the patient experienced hypoxia, was intubated and started on nasal canula therapy.It was further reported that the patient was found to be non-responsive the next day.Brain attack was called with subsequent head computerized tomography (ct).Imaging showed large left occipitoparietal and temporal parenchymal hemorrhage with extensive regional vasogenic edema and mass effect.There was approximately 23 mm of left-to-right mid-line shift with both subfalcine and descending transtentorial herniation.Also, there was extensive mass effect on the mid-brain and superior pons.The patient was transitioned to comfort measures and subsequently expired.It was further reported that the source of bacteremia was unknown and that implantable pulse generator (ipg) and cardiac re-synchronization therapy was also performed.It was also reported that anesthetic medications was administered.Based on the available information, the device may have caused or contributed to the reported event.Based on the risk documentation, possible causes of the reported low flow event may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, poor vad filling, and/or inappropriate pump rotational speed.Per the instructions for use, cardiac arrhythmia, neurologic dysfunction, hypertension and infection are known potential complications associated with the implantation of a vad.Based on a review of past adverse events, it was noted that the patient had a history of infection 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.

• 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: 13759201
• MDR Text Key: 290069236
• Report Number: 3007042319-2022-02969
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2022
• Device Model Number: MCS1705PU
• Device Catalogue Number: MCS1705PU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 03/14/2022
• Supplement Dates Manufacturer Received: 03/16/2022; 03/25/2022; 04/18/2022; 05/06/2022; 06/09/2022; 08/08/2022
• Supplement Dates FDA Received: 03/31/2022; 04/14/2022; 04/29/2022; 05/12/2022; 06/20/2022; 08/10/2022
• Date Device Manufactured: 08/31/2020
• 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; Required Intervention; Death; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White