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 Diarrhea (1811); Fatigue (1849); Headache (1880); Intracranial Hemorrhage (1891); Nausea (1970); Sepsis (2067); Vomiting (2144)

Event Date 07/13/2022

Event Type  Death  

Manufacturer Narrative

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 reported that the patient presented with complaint of nausea, vomiting and diarrhea for the past few days.The patient was feeling better the day before with no nausea or vomiting but was very tired, and then developed a headache.Upon admission, creatinine (cr) was 12, blood urea nitrogen (bun) was 85, white blood cell count was in the 20s, and the site believed the patient was septic.Brain/head computerized tomography (ct) showed a right frontotemporal hemorrhage with associated subarachnoid hemorrhage.It was noted that the patient¿s international normalized ratio (inr) had been therapeutic at 2.5.Blood cultures were positive for gram-negative rods and the site believed the stroke was related to the infection.Two days later, the brain bleed had progressed, and the midline shift was worse.The patient was still septic and continued to be monitored.It was also reported that the family decided to discontinue support.The patient subsequently ceased to breath (ctb) and expired.The cause of death was head bleed in the setting of infection.

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 presented with complaints of nausea, vomiting, and diarrhea, and then developed a headache.Upon admission, the site believed the patient was septic, and a brain/head computerized tomography (ct) showed a right frontotemporal hemorrhage with associated subarachnoid hemorrhage.Blood cultures were positive for gram-negative rods and the site believed the stroke was related to the infection.Two days later, the brain bleed had progressed, and the midline shift was worse.The patient was still septic and continued to be monitored.The family decided to discontinue support, and the patient subsequently expired.Based on the available information, the device may have caused or contributed to reported eve nt.Per the instructions for use, neurological dysfunction, sepsis, and death are known potential complications associated with the implantation of a vad.There was no evidence that the patient had a history of neurological dysfunction or 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: 15085781
• MDR Text Key: 296404090
• Report Number: 3007042319-2022-06689
• 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
• Report Date: 09/20/2022

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: 09/30/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 09/14/2022
• Supplement Dates FDA Received: 09/20/2022
• Date Device Manufactured: 09/24/2018
• 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: DVFB1D4 ICD, 6947M55 LEAD
• Patient Outcome(s): Death
• Patient Age: 16 YR
• Patient Sex: Female