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U.S. Department of Health and Human Services

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

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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 1103
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiomyopathy (1764); Right Ventricular Dysfunction (2054); Heart Failure (2206); Cardiovascular Insufficiency (4445); Heart Failure/Congestive Heart Failure (4446)
Event Date 09/08/2020
Event Type  Injury  
Manufacturer Narrative
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 ventricular assist device (vad) patient experienced right heart failure with severe right ventricle dysfunction. The patient was treated with intravenous (iv) therapy and the vad remains 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/DRIVELINE
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 Key10555171
MDR Text Key207578175
Report Number3007042319-2020-05768
Device Sequence Number1
Product Code DSQ
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
Type of Report Initial,Followup,Followup,Followup
Report Date 02/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2021
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 Received01/29/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/22/2019
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: 09/18/2020 Patient Sequence Number: 1
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