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 Unspecified Infection (1930); Pleural Effusion (2010); Transient Ischemic Attack (2109)

Event Date 01/31/2021

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.This information was received from the mechanical circulatory support product surveillance registry study.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that two days post implant, the ventricular assist device (vad) patient had a temperature maximum of thirty-nine (39) degrees celsius and sputum cultures were taken which had gram positive cocci (gpc) and gram negative rods (gnr) with moderate growth and normal respiratory flora.The patient was given vancomycin and zosyn antibiotics.The patient also experienced right pleural effusion; an x-ray showed trace pleural fluid and thickening within the minor fissure.The patient also had a transient ischemic attack (tia) at fourteen (14) days post implant within the same hospitalization with a mild left facial droop, a slight loss of the left nasolabial fold and a very mild asymmetric smile.A head computerized tomography (ct) was done twice which showed no clear changes of a cerebrovascular accident (cva).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 investigation completion.Product event summary: the ventricular assist device (vad) was not returned for evaluation.This complaint is associated with a clinical adverse event.Review of the sterility certificate confirmed that the associated device met all requirements for release.Information provided by the site indicated that two days post implant, the ventricular assist device (vad) patient had a temperature maximum of thirty-nine (39) degrees celsius and sputum cultures were taken which had gram positive cocci (gpc) and gram negative rods (gnr) with moderate growth and normal respiratory flora.The patient was given vancomycin and zosyn antibiotics.The patient also experienced right pleural effusion; an x-ray showed trace pleural fluid and thickening within the minor fissure.The patient also had a transient ischemic attack (tia) at fourteen (14) days post implant within the same hospitalization with a mild left facial droop, a slight loss of the left nasolabial fold and a very mild asymmetric smile.A head computerized tomography (ct) was done twice which showed no clear changes of a cerebrovascular accident (cva).Based on the available information, the device may have caused or cont ributed to the reported event.Per the instructions for use, pleural effusion and infection 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

A supplemental report is being submitted for an update to: -b5.Desc evt problem 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 pulmonary infection was possibly related to aspiration.

Manufacturer Narrative

A supplemental report is being submitted as the investigation summary was revised.Product event summary: the ventricular assist device (vad) (b)(6) was not returned for evaluation.This complaint is associated with a clinical adverse event.Review of the sterility certificate confirmed that the associated device met all requirements for release.Information provided by the site indicated that two days post implant, the ventricular assist device (vad) patient had a temperature maximum of thirty-nine (39) degrees celsius and sputum cultures were taken which had gram positive cocci (gpc) and gram negative rods (gnr) with moderate growth and normal respiratory flora.The patient was given vancomycin and zosyn antibiotics.The patient also experienced right pleural effusion; an x-ray showed trace pleural fluid and thickening within the minor fissure.The patient also had a transient ischemic attack (tia) at fourteen (14) days post implant within the same hospitalization with a mild left facial droop, a slight loss of the left nasolabial fold and a very mild asymmetric smile.A head computerized tomography (ct) was done twice which showed no clear changes of a cerebrovascular accident (cva).Additional information from the site indicated that the pulmonary infection was possibly related to aspiration.Based on the available information, the device may have caused or contributed to the reported event.Per the instructions for use, pleural effusion and infection 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, is sues 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: 13111520
• MDR Text Key: 282918993
• Report Number: 3007042319-2021-08468
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2022
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2023
• Date Device Manufactured: 08/12/2020
• 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): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Ethnicity: Hispanic
• Patient Race: White