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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 1103
Device Problem Malposition of Device (2616)
Patient Problems Syncope (1610); Hypovolemia (2243)
Event Date 06/18/2020
Event Type  Injury  
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. This information was received from the destination therapy post approval study. 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 the patient had a syncope event with an unclear etiology but possibly due to hypovolemia, a small left ventricle (lv) cavity, or ventricular assist device (vad) malposition. Orthostatic symptoms largely resolved with abdominal binders and compression stockings. The vad is still in use. No further patient complications have been reported as a result of this event.
 
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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 Key10290905
MDR Text Key199318755
Report Number3007042319-2020-05000
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00888707003261
UDI-Public00888707003261
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Model Number1103
Device Catalogue Number1103
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 Received07/31/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/04/2018
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: 07/17/2020 Patient Sequence Number: 1
Treatment
DVFB1D4 - ICD, 6935M62 - LEAD
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