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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

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THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA Back to Search Results
Model Number 106015
Device Problem Partial Blockage (1065)
Patient Problem Thrombus (2101)
Event Date 04/19/2018
Event Type  Injury  
Manufacturer Narrative
The patient¿s weight was not provided. Approximate age of device- 4 years and 6 months. The patient remains ongoing with the lvad device. No further information was provided. A supplemental report will be submitted when the manufacturer's investigation is completed.
 
Event Description
The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2013. It was reported that the patient¿s log file was submitted for review due to suspected possible obstruction given that the patient¿s intracardiac hemodynamics did not improve despite speed changes. The power appears to be lower than expected based upon the speed however log file and reported the powers and flows to be within the normal parameters and there is no evidence of any obstruction. Additional information has been requested but not provided.
 
Manufacturer Narrative
The pump remains in use supporting the patient and was not available for evaluation. A direct correlation between the device and the suspected thrombus and reported hemolysis could not be conclusively determined through this evaluation. The log file submitted was unremarkable. The account reported a suspected obstruction given that the patient¿s intracardiac hemodynamics did not change despite the speed changes. It was later communicated that there were no other clinically significant changes and no treatment was reported. The patient was reportedly stable and the patient was being clinically monitored. The hmii lvas ifu lists device thrombosis and hemolysis as adverse events that may be associated with the use of the heartmate ii left ventricular assists system and explains that pump power is a direct measurement of motor voltage and current; therefore, changes in pump speed, flow, or physiological demand can affect pump power. This ifu explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling and outlines the recommended anticoagulation therapy and inr range.
 
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Brand NameHEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
Type of DeviceLEFT VENTRICULAR ASSIST SYSTEM
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 95488
MDR Report Key7524740
MDR Text Key108604613
Report Number2916596-2018-02099
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
PMA/PMN Number
P060040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 01/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2016
Device Model Number106015
Device Catalogue Number106015
Other Device ID Number00813024011224
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/10/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/17/2018 Patient Sequence Number: 1
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