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

Model Number	1125
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Blood Loss (2597)
Date of Event	11/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that shortly after implant the patient experienced symptoms of tamponade and had to return to the operating room (or).On the same day, the patient showed signs of bleeding.Upon revisiting the operating room, it was noted that there was a crack/small hole in the outflow graft, close to the pump.The outflow graft was shortened and the patient was closed up.The patient began exhibiting signs of bleeding the next day.Therefore, the outflow graft was explanted and exchanged.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the outflow graft was returned for evaluation.Failure analysis of the returned segment of outflow graft revealed that the device passed visual examination.Of note, it was reported that after the initial bleeding, the section of outflow graft with the observed tear was removed and the outflow graft shortened.The removed section was not returned for evaluation.As a result, the reported event could not be confirmed due to insufficient evidence.There is no evidence of a device malfunction that may have prevented the devices from performing as intended.Based on risk documentation and historical review of similar events, potential factors that may have contributed to the reported event include but not limited to a tear within the outflow graft and/or a loose graft connection.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.
Additional Manufacturer Narrative
Supplemental mdr report is being submitted to include the associated fda z-number issued for the reported issue captured in this report.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 - OUTFLOW GRAFT
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9296864
• Report Number: 3007042319-2019-12447
• Device Sequence Number: 10872054
• Product Code: DSQ
• UDI-Device Identifier: 00888707000222
• UDI-Public: 00888707000222
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2023
• Device Model Number: 1125
• Device Catalogue Number: 1125
• Device Lot Number: 17319906-1058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 02/06/2020; 05/22/2020
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 02/07/2020; 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2058-2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1104 VAD; 1104 VAD
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention