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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 Problems Partial Blockage (1065); High Readings (2459)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 02/12/2018
Event Type  Injury  
Manufacturer Narrative
The initial submission of this event was reported by the manufacturer under mfr report # 2916596-2018-00914. This report is being submitted as additional information approximate age of device - 11 months. Manufacturer's investigation conclusion: a direct correlation between heartmate ii lvas, and the report that the patient had an outflow revision and thrombectomy could not conclusively be established through this evaluation. Additionally, it was reported that there was a well-organized thrombus circumferentially around the outflow dacron graft, however, a specific cause for this finding could not conclusively be determined through this evaluation. Analysis of the log files provided by the account confirmed unsustained power elevations; however, a specific cause for this finding could not be conclusively determined. The patient remains ongoing on heartmate ii lvas, serial number (b)(4). The hmii lvas ifu lists device thrombosis as an adverse event that may be associated with the use of the heartmate ii left ventricular assist system. This ifu 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 also explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling. This ifu outlines the indications of pump thrombosis, as well as how to respond to such events. This document provides details regarding the surgical procedures used to prime and install the sealed outflow graft. This section explains that the sealed outflow graft must not be kinked or positioned where it could abrade against a pump component or body structure. In addition, this document also outlines the recommended anticoagulation therapy and inr range. No further information was provided. The manufacturer is closing the file on this event.
 
Event Description
The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017. It was reported that the patient underwent an outflow graft revision and thrombectomy on (b)(6) 2018 after power elevations were observed. The patient was discharged to home in stable condition. No additional information was provided. Additional information stated that during the outflow graft revision, no twist was found in the outflow graft. It was stated that the bend relief collar, as well as the bend relief were densely scarred to the surrounding structures. The bend relief collar was removed. Next, the bend relief was cut longitudinally for about 3 cm, taking care not to injure the outflow graft underneath. There was a well-organized thrombus circumferentially around the outflow dacron graft, which was removed. The outflow graft was disconnected from the outflow conduit of the blood pump by untwisting the screw using the wrench. Next, thrombectomy was performed from the outflow dacron graft using the metal sucker with a tip off. The clot appeared relatively fresh and sucked out with ease without much adherence to the dacron graft from the inside. The dacron graft was carefully inspected and no other abnormalities were seen.
 
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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
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 95488
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key7965306
MDR Text Key123715780
Report Number2916596-2018-04532
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P060040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2019
Device Model Number106015
Device Catalogue Number106015
Device Lot Number5823554
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/06/2017
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: 10/15/2018 Patient Sequence Number: 1
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