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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
Catalog Number 106015
Device Problem Partial Blockage (1065)
Patient Problems Hemolysis (1886); Thrombus (2101)
Event Date 02/15/2018
Event Type  Injury  
Manufacturer Narrative
The initial submission of this event was reported by the manufacturer under mfr report # 2916596-2018-01412. This report is being submitted as additional information. Approximate age of device ¿ 5 months. Manufacturer's investigation conclusion: the report of suspected thrombus could not be confirmed. It was reported that the patient presented with elevated ldh and a pump exchange was performed. A thrombus was noted in the inlet and outlet stators and despite multiple requests for product return, the pump has not been received to date. Device thrombosis and hemolysis are listed as adverse events that may be associated with the use of heartmate ii left ventricular assist system and information regarding how to monitor and respond to such events can be found in the heartmate ii instruction for use. A review of the device history records revealed the device met applicable specifications. No further information is available. 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 presented with elevated lactate dehydrogenase (ldh) and was admitted into the hospital on (b)(6) 2018, and was given tissue plasminogen activator without a resolution of the hemolysis. The patient was administered iv heparin; however, their ldh continued to rise over 1400 u/l. The patient was asymptotic. A ramp echocardiogram showed the pump was not functioning properly and the left ventricle was decompressing. On (b)(6) 2018, the patient¿s ldh was over 1800 u/l, and subsequently their pump was exchanged. Only the pump body was exchanged. The explanted pump was examined at the hospital and a thrombus was visualized at the inflow conduit and outflow graft. The patient¿s pump parameters were observed to be normal after the original pump was exchanged.
 
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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 Key8131797
MDR Text Key129382834
Report Number2916596-2018-05404
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 12/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2020
Device Catalogue Number106015
Device Lot Number6109652
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 Received11/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/16/2017
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: 12/04/2018 Patient Sequence Number: 1
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