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U.S. Department of Health and Human Services

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

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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 1104
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Right Ventricular Dysfunction (2054); Right Ventricular Failure (2055); Thrombus (2101)
Event Date 05/09/2020
Event Type  Death  
Manufacturer Narrative
This device is used for treatment not diagnosis. The ventricular assist system is indicated for use as a bridge to cardiac trans plantation 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. 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 Description
It was reported that prior to implantation of the ventricular assist device (vad) the patient experienced poor right ventricular function and was placed on extracorporeal membrane oxygenation (ecmo). The vad was implanted. A thrombus was found in the cannula of the ecmo that supported the right side of the heart. It was stated that due to the thrombus, the patient right heart failure worsen and two days later the patient subsequently expired.
 
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Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Type of DeviceVENTRICULAR (ASSIST) 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 Key10072892
MDR Text Key191522473
Report Number3007042319-2020-03233
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2021
Device Model Number1104
Device Catalogue Number1104
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/23/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/19/2020 Patient Sequence Number: 1
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