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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 Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2019
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. Product event summary: a pump with an unknown serial number and outflow graft with unknown lot number were not returned for evaluation. Review of the controller log files could not be conducted since log files were not available. As a result, the reported "low flow" event could not be confirmed. There is no evidence to indicate that a device malfunction or performance issue caused or contributed to the reported event. Based on the available information, the most likely root cause of the reported event can be attributed to thrombus 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, and the patient's complex post-operative course. There are possible patient, pharmacological and procedural factors that may have contributed to this event. Additional products: brand name: heartware ventricular assist system ¿ pump, medical device: model #: unk / catalog #: unk / expiration date: unk / serial #: unk, udi #: (b)(4). Device available for evaluation? no. Device mfg date: unk. Labeled for single use? yes. (b)(4). This event was reported in the q4 2019 data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support. The data registry does not contain device identifying information or event date 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. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient was hospitalized after the ventricular assist device (vad) had persistent low flow alarms. The patient was taken to the operating room for a redo sternotomy and outflow graft release. The outflow graft and vad remain in use. No patient complications were reported as a result of the event. This event was reported in the q4 2019 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support. The data registry does not contain device identifying information or event date 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 Key9878319
MDR Text Key196482615
Report Number3007042319-2020-02423
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2020
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 Received02/25/2020
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: 03/25/2020 Patient Sequence Number: 1
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