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 Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/18/2022

Event Type  Injury  

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 a non-contrast helical computerized tomography (nchct) demonstrated chronic infarcts.The patient was not a good candidate for a transplant but due to higher stroke risk, the patient was offered and accepted re-implantation of a competitor device.The ventricular assist device (vad) was removed from service.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for additional information and corrections.Additional information was received via medwatch form; a4 updated and g2 updated to include user facility.A correction has been noted to g2 and h10 indicating that information was received from a clinical study, 5a and 5b were corrected to include patient race and ethnicity, and b7 corrected to include hypertension.This information was received from the mechanical circulatory support product surveillance registry study.This supplemental is based on the receipt of a 3500a report.Section f has been updated to reflect that report.F1 user facility f2 uf/importer report number: (b)(4), f3 user facility name/address: (b)(6) hospital, (b)(6), f4 contact person: (b)(6) f5 phone number: (b)(6), f6 date user facility became aware of the event: unknown f7 type of report: initial f8 date of this report: jul-2022 f9 approximate age of device: f10 event problem codes: f11 report sent to fda: f12 location where event occurred: hospital, other: or f13 report sent to manufacturer: yes, jul-2022 f14 manufacturer name and address mfr.Name: medtronic, plc addl: 14400 nw 60th ave city: miami lakes state: fl zip: 33014 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 an update to: b5.Desc evt problem -h6.Patient codes (ime/annex e) 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 vad was exchanged due to device thrombosis.

Manufacturer Narrative

A supplemental is being submitted for additional information.Product event summary: ventricular assist device (vad) (b)(6) was returned for evaluation.Review of the manufacturing records confirmed that the associated pump met all requirements for release.Log file analysis was not conducted since log files covering the reported event date were not available.Failure analysis of the returned pump revealed that the device passed functional testing.Visual inspection revealed damage at the connection between the strain relief and header.This is an additional observation not related to the reported event.Given that this damage was not present prior to release of the device, it can likely be attributed to the handling of the device during or after the explant procedure.Dimensional verification revealed that the front preload measurement and front housing disc curvature were found to be deviating from release specifications.Capa pr00578223 was opened to investigate post-explant issues found during failure analysis of returned pumps.Internal pathological report revealed no evidence of thrombus within the device.Information received from the site indicated that a non-contrast helical computerized tomography (nchct) demonstrated chronic infarcts, and the patient was at a higher risk of stroke.It was further reported that the ventricular assist device (vad) was exchanged due to device thrombosis.Based on the available information, the device may have caused or contributed to the reported event.Per the instructions for use, device thrombus and neurological dysfunction are known potential complications associated with the implantation of a vad.Based on the review of past adverse events for this patient, it was noted that the patient had a history of infarcts, stroke, and 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 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.

• 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: 15103336
• MDR Text Key: 296581070
• Report Number: 3007042319-2022-06713
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2021
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2019
• 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
• Treatment: DVFB1D1 ICD, 694765 LEAD
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 140 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American