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

Model Number 1103

Device Problems Increase in Suction (1604); Pumping Problem (3016)

Patient Problems Hemolysis (1886); Intracranial Hemorrhage (1891); Hyperbilirubinemia (1903); Renal Failure (2041); Hematuria (2558); Thrombosis/Thrombus (4440); Lactate Dehydrogenase Increased (4567)

Event Date 04/15/2022

Event Type  Death  

Manufacturer Narrative

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 was admitted with coke colored urine, hypertension and low flows that triggered low flow alarms.The ventricular assist device (vad) exhibited suction alarms and power consumption below normal range.A ventricular assist device (vad) inflow cannula thrombus was suspected.Patient plasma free hgb went from 28 to 90.Hemolysis labs and right heart catheterization (rhc) were performed, the vad speed was adjusted multiple times, but produced no change to hemodynamics.The patient was started on dobutamine 3 mcg for inotropic support and patient was started on heparin gtt which has been discontinued.Palliative care was consulted as the patient developed acute kidney injury (aki) on chronic kidney disease(cdk) stage iii and worsening renal function, likely in setting of pigment nephropathy from the hemolysis.The patient cannot be placed on anticoagulant due to multifocal subarachnoid hemorrhage (sah) and international normalized ratio (inr) not monitored.During the days the patient continues to make urine 1.3l and creatinine remains at 2.7.Plasma free hemoglobin (pfh) and (lactate dehydrogenase) ldh elevated (38, 1044 respectively).Patient was not an exchange or transplant candidate and was moved toward comfort care, were the patient subsequently expired.

Event Description

It was further reported that the patient's mean arterial pressure (map) was recorded at 125 and hydralazine was given intravenously (iv).Hyperbilirubinemia was also noted as well as rapidly increasing hemolysis markers.

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.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A supplemental report is being submitted for a correction to: imf (annex f) health impact, added f2203 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 also reported that the patient's ldh was 441, 1044 and 2133, their liver function tests were elevated and their right atrial pressure (rap) was 22.It was also reported that the right heart catheterization demonstrated no changes in pulmonary capillary wedge pressure (pcwp) or cardiac output when the vad speed was increased.

Manufacturer Narrative

A supplemental report is being submitted for additional event details.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 an electrocardiogram was performed and revealed sinus rhythm.

Manufacturer Narrative

A supplemental report is being submitted for an update to: -b5.Desc evt problem -b6.Laboratory data 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: (b)(6) was not returned for evaluation.Review of the controller log files revealed a sudden decrease in power consumption and estimated flows beginning on (b)(6) 2022 to parameters below normal operating range and one hundred and fifty (150) low flow alarms have been logged since (b)(6) 2022.Additionally, five (5) suction alarms were logged since (b)(6) 2022.As a result, the reported low flow, low power, and suction events were confirmed.Information received from the site indicated that the patient was admitted with coke colored urine and hypertension.A ventricular assist device (vad) inflow cannula thrombus was suspected.Patient plasma free hgb went from 28 to 90.Hemolysis labs and right heart catheterization (rhc) were performed, the vad speed was adjusted multiple times, but produced no change to hemodynamics.The patient was started on dobutamine 3 mcg for inotropic support and patient was started on heparin gtt which has been discontinued.Palliative care was consulted as the patient developed acute kidney injury (aki) on chronic kidney disease (cdk) stage iii and worsening renal function, likely in setting of pigment nephropathy from the hemolysis.The patient cannot be placed on anticoagulant due to multifocal subarachnoid hemorrhage (sah) and international normalized ratio (inr) not monitored.During the days the patient continues to make urine 1.3l and creatinine remains at 2.7.Plasma free hemoglobin (pfh) and (lactate dehydrogenase) ldh elevated (38, 1044 respectively).It was further reported that the patient's mean arterial pressure (map) was recorded at 125 and hydralazine was given intravenously (iv).Hyperbilirubinemia was also noted as well as rapidly increasing hemolysis markers.An electrocardiogram was performed and revealed sinus rhythm.Additional information received from the site indicated that the patient's ldh was 441, 1044 and 2133, their liver function tests were elevated and their right atrial pressure (rap) was 22.It was also reported that the right heart catheterization demonstrated no changes in pulmonary capillary wedge pressure (pcwp) or cardiac output when the vad speed was increased.Patient was not an exchange or transplant candidate and was moved toward comfort care, were the patient subsequently expired.Based on the available information, the device may have caused or contributed to the reported event.Based on the risk documentation, multiple factors may have contributed to the reported suction and low flow/power events including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, inappropriate pump rotational speed, and/or poor vad filling.Per the instructions for use, device thrombus, hypertension, renal dysfunction, neurologic dysfunction, and death are known potential complications associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had a history of thrombus, renal dysfunction and neurological dysfunction.Of note, the patient's reported medical history indicated the patient has a hypertension.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, th e 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: 14279935
• MDR Text Key: 290662096
• Report Number: 3007042319-2022-04943
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707002639
• UDI-Public: 00888707002639
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2018
• 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
• Treatment: 6935M62 LEAD, DVFC3D4 ICD
• Patient Outcome(s): Death
• Patient Age: 54 YR
• Patient Sex: Male