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

Model Number 1103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Ischemia (1942); Pleural Effusion (2010); Shock (2072); Heart Failure/Congestive Heart Failure (4446)

Event Date 03/26/2020

Event Type  Death  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.This event was collected during a review of patient records with the healthcare facility.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there were no known ventricular assist device (vad) issues, but the patient had right ventricle (rv) failure and systemic inflammatory response syndrome (sirs) which lead to multiple system organ failure (msof) and the patient subsequently expired.No further information is available.This event was collected during a review of patient records with the healthcare facility.

Manufacturer Narrative

A supplemental report is being submitted for investigation completion.Product event summary: the ventricular assist device (vad) was not returned for evaluation.This complaint is associated with a clinical adverse event.Information received from the site indicated that the patient experienced right ventricle (rv) failure and systemic inflammatory response syndrome (sirs) which lead to multiple system organ failure (msof) and the patient subsequently expired.Based on the available information, there is no evidence to indicate that a device malfunction or performance issue caused or contributed to the reported event.Per the instructions for use, right ventricular failure, multi-organ failure, and death are known potential complications associated with the implantation of a vad.There was no evidence that the patient had a history of similar adverse 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

This regulatory report is being submitted as part of a retrospective review and remediation per d00700870.Corrected sections: - b3 date of event: corrected from 2020-05-02 to 2020-03-26 to better reflect the series of adverse events.- b5 desc evt problem: corrected in its entirety to include all adverse event experienced by the patient, diagnosis and intervention performed - h6 patient codes (ime/annex e), imf (annex f) health impact: corrected to include new annex codes that reflect the reported event.- h10 addt manufacturer for mdr: corrected the product event summary to include the reported event for adverse event product event summary: ventricular assist device (vad) (b)(6) was not returned for evaluation.This complaint is associated with a clinical adverse event.Information received from the site indicated that approximately two and a half months post vad implant, the patient experienced acute on chronic heart failure and was transferred back to the intensive care unit (icu) and had an increase of diuretics medication.Approximately twenty-six days later, the patient developed pleural effusion that required a chest tube.Eight days later, the patient experienced right upper extremity (rue) ischemia which resulted in a thrombectomy and fasciotomy procedure in the operating room (or) of the right upper extremity.It was further reported that the following day, the patient experienced vasoplegia/shock and the patient lost distal arterial pulse in their rue and subsequently went to the or with vascular surgery and ortho for hand for thrombectomy and forearm as well as a fasciotomy.Of note, the patient remained on high dose pressors without improvement.Two days thereafter, it was reported that there were no known vad issues, but the patient had right ventricle (rv) failure and systemic inflammatory r esponse syndrome (sirs) which led to multiple system organ failure (msof) and the patient subsequently expired.Based on the available information, the device may have caused or contributed to the reported event.Per the instructions for use, pleural effusion, right ventricular failure, multi-organ failure, and death are known potential complications associated with the implantation of a vad.There was no evidence that the patient had a history of similar adverse 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 is 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.

Event Description

It was reported that approximately two and a half months post ventricular assist device (vad) implant, the patient experienced acute on chronic heart failure and was transferred back to the intensive care unit (icu) and had an increase of diuretics medication.Approximately twenty-six days later, the patient developed pleural effusion that required a chest tube.Eight days later, the patient experienced right upper extremity (rue) ischemia which resulted in a thrombectomy and fasciotomy procedure in the operating room (or) of the right upper extremity.It was further reported that the following day, the patient experienced vasoplegia/shock and the patient lost distal arterial pulse in their rue and subsequently went to the or with vascular surgery and ortho for hand for thrombectomy and forearm as well as a fasciotomy.Of note, the patient remained on high dose pressors without improvement.Two days thereafter, it was reported that there were no known vad issues, but the patient had right ventricle (rv) failure and systemic inflammatory response syndrome (sirs) which led to multiple system organ failure (msof) and the patient subsequently expired.No further information is available.

• 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: 12336062
• MDR Text Key: 267048675
• Report Number: 3007042319-2021-05703
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707003261
• UDI-Public: 00888707003261
• 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
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2021
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2022
• Date Device Manufactured: 08/02/2019
• 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): Death
• Patient Age: 58 YR
• Patient Sex: Male