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U.S. Department of Health and Human Services

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

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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - OUTFLOW GRAFT VENTRICULAR (ASSIST) BYPASS Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 08/24/2018
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. Event summary: an outflow graft with unknown lot number was not returned for evaluation. Log file analysis could not be performed since log files covering the reported event date were not available for analysis. The reported event could not be confirmed due to insufficient evidence. This event was reported in the 2019 euromacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support. The data registry does not contain patient or device identifying information therefore cannot be correlated to any previously received report of the event. Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient was hospitalized with a malfunction of the outflow graft that required surgical intervention. The outflow graft remains in use. No further patient complications have been reported as a result of this event. This event was reported in the 2019 euromacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support. The data registry does not contain patient or device identifying information and therefore cannot be correlated to any previously received report of the event. Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event.
 
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Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM - OUTFLOW GRAFT
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 Key9343255
MDR Text Key167144399
Report Number3007042319-2019-13846
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 company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/21/2019
Was Device Evaluated by Manufacturer? No Answer Provided
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: 11/19/2019 Patient Sequence Number: 1
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