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

Model Number	1125
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Pulmonary Edema (2020)
Date of Event	09/04/2019
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.Concomitant medical products: dtmb1d1 icd, implanted: (b)(6) 2017; 693565 lead, implanted: (b)(6) 2013; 2088tc lead, implanted: (b)(6) 2013; 1258t lead, implanted: (b)(6) 2013.Investigation of this event is pending, and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was hospitalized as the outflow graft had a stricture which was noted via computerized tomography angiography (cta).There was inadequate or low flow rate via the outflow graft.An echocardiogram showed poor unloading of the left ventricle (lv) and chest x-ray shows pulmonary edema.A stent was placed to open flow to the outflow graft and the patient was treated with lasix intravenous (iv).The outflow graft remains in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
A supplemental report is being submitted for investigation completion.Product event summary: the outflow graft was not returned for evaluation.The reported low flow event could not be confirmed via re view of log files since log files covering the reported event date were not provided for analysis.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Of note, it was reported that computerized tomography angiography revealed that the outflow graft had a stricture; a stent was placed "to open flow." based on the available information and risk documentation, the most likely root cause of the reported low flow event can be attributed, but not limited, to constriction at the outflow graft.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 - OUTFLOW GRAFT
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10155566
• Report Number: 3007042319-2020-03586
• Device Sequence Number: 16685376
• Product Code: DSQ
• UDI-Device Identifier: 00888707000222
• UDI-Public: 00888707000222
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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: 01/31/2022
• Device Model Number: 1125
• Device Catalogue Number: 1125
• Device Lot Number: 16135375-9778
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1103 VAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 60