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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
Device Problems Malposition of Device (2616); Pumping Problem (3016)
Patient Problems Death (1802); Unspecified Infection (1930); Thrombosis (2100); Cardiogenic Shock (2262)
Event Date 01/01/2017
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. Medtronic was made aware of this event through a search of literature publications. It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events. This information is based entirely on journal literature. All information provided is included in this report. Patient information is limited due to confidentiality concerns. Multiple patients and multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique device serial numbers. The baseline gender/age of the patients represented in the article is male/61 years old. The date of death is not available at the time of this report as there is no indication of specific serial number/patient information. Without a lot number or device serial number, the manufacturing date cannot be determined. Since no device id was provided, it is unknown if this event has been previously reported. Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article: characteristics and outcomes of lvad patients who undergo pump exchange: axial flow vs. Centrifugal flow therapy. The journal of heart and lung transplantation, 2017; 36(4 supplement 1):s99-s100. Additional information has been requested regarding the cause of the events and disposition of the devices, but it was not available at the time of this report. If additional information is received, the event will be updated and a supplemental report will be sent. 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
A journal article was reviewed which contained information regarding ventricular assist devices (vads). The article compared the incidence, etiology and outcomes after pump exchange surgery in patients using axial flow versus centrifugal flow left vads. Multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique device serial numbers. The article reports one patient death while on centrifugal flow vad support occurring after pump exchange, however the cause of death was not reported. Reasons for pump exchange in the centrifugal flow vad cohort included pump thrombosis, cardiogenic shock with low flow alarms, cannula malposition and infection. The status of the vad is unknown.
 
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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 Key10156259
MDR Text Key195213835
Report Number3007042319-2020-03593
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,literatur
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2020
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
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: 06/16/2020 Patient Sequence Number: 1
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