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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 Problems Death (1802); Hemolysis (1886); Thrombus (2101)
Event Date 02/20/2018
Event Type  Death  
Manufacturer Narrative
This report is a continuation of patient's thrombus, device exchange and death previously reported under mfr# 2916596-2018-00889. History of thrombus previously reported under mfr # 2916596-2017-02829. Approximate age of device- 2 years, 1 month. The device was returned for investigation. The evaluation is not yet complete. 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 on (b)(6) 2016. It was previously reported that the pump showed intermittent increase in flows and power. It was reported on (b)(6) 2018 that the patient's lactate dehydrogenase (ldh) levels continued to rise despite treatment with bivalirudin. A kink was seen in the outflow graft via 3d imaging. It was noted that the patient had a history of pump thrombosis. The patient underwent a pump exchange on (b)(6) 2018. On (b)(6) 2018, the family decided to withdraw care and the patient expired. The cause of death was reported as post-surgical complications. No issues were reported with the second pump. No further information was provided. (b)(4) was received on 04feb2019. This complaint is being recreated for the evaluation of the pump.
 
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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 Key8352558
MDR Text Key136579155
Report Number2916596-2019-00687
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 health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2018
Device Model Number106015
Device Catalogue Number106015
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/31/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/20/2015
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: 02/19/2019 Patient Sequence Number: 1
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