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

Model Number 1103

Device Problems Obstruction of Flow (2423); Pumping Problem (3016)

Patient Problems High Blood Pressure/ Hypertension (1908); Thrombosis/Thrombus (4440); Lactate Dehydrogenase Increased (4567)

Event Date 11/28/2021

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional information has been requested regarding intervention, 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.

Event Description

It was reported that the patient was hospitalized with hypertension on arrival and constant low flow alarms.On arrival the patient had blood pressure of 100, lactate dehydrogenase of 279 and an international normalized ratio of 1.7.Once blood pressure was undercontrol the low flow alarms continued.A computed tomography revealed a 75-90% occlusion within compressing the ventricular assist device (vad) outflow graft just proximal to and including anastomosis with ascending aorta.The vad remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

### a supplemental report is being submitted for additional event details.The event description and the annex f code has been updated to reflect that the vad has been exchanged to a competitor's vad.Additional products: d4: lot#: 1407752 h6: imf code(s): f1903 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 vad exchange to a competitor's vad was performed.

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: d1: heartware ventricular assist system ¿ outflow graft d4: model #: 1125 / catalog #: 1125/ expiration date: 31-aug-2022 / lot #: 1407752 udi #: (b)(4).D10: no h3: no, device evaluation anticipated, but not yet begun h4: mfg date: 31-aug-2020 h5: no h6: patient ime code(s): e0514, e2204, e2320 h6: imf code(s): f08, f2203 h6: img code(s): g04019, g04105 h6: fda device code(s): a1409 h6: fda results code(s): c21 h6: fda conclusion code(s): d16.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's "inr goals were at 2.0 to 2.5 due to a history of gastrointestinal bleed (gib)" and that anticoagulation was subtherapeutic.The patient was treated surgical with a cardiac stent.

Manufacturer Narrative

A supplemental report is being submitted for additional event details.The event description, the relevant history and the annex f code has been updated.Intervention required has been selected for outcome attributed to adverse event as related to the additional information.And correction , the initial regulatory report listed the concomitant product as ddb1d4 ics, 5076-52; 6947m62 leads.That has bee update to reflect each device and to correct the s in ics to icd.Additional products: d4: lot#: 1407752 dev rtn to mfr? yes delete if no h6: imf code(s): f19, f23 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 patient history (b7) and explant date (6b).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)) and the associated outflow graft (lot 1407752) were not returned for evaluation.The reported low flow event was confirmed through log file analysis which revealed a sudden, sustained decrease in power consumption and estimated flows beginning on (b)(6) 2021, leading to parameters below the normal operating range, and 31 low flow alarms recorded since (b)(6) 2021.Information provided by the site indicated that, in addition to low flows, the patient presented with hypertension.A computed tomography revealed a 75-90% occlusion of the outflow graft just proximal to, and including, anastomosis with the ascending aorta.The patient was treated surgically with a cardiac stent.It was further reported that the vad was exchanged.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, and/or poor vad filling.Per the instructions for use, 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 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.Additional information: outflow graft: d10: no h3: yes h6: fda method code(s): b17 h6: fda results code(s): c20 h6: fda conclusion code(s): d12 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: 12925414
• MDR Text Key: 281683023
• Report Number: 3007042319-2021-08259
• 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: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• 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: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2018
• 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: DDMB1D4 ICD, 5076-52 LEAD, 6947M62 LEAD; DDMB1D4 ICS, 5076-52, 6947M62 LEADS
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male