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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE

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THORATEC CORPORATION HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE Back to Search Results
Catalog Number 106015
Device Problems Partial Blockage (1065); High Readings (2459)
Patient Problem Hemolysis (1886)
Event Date 01/05/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Approximate age of device ¿ 2 months. The patient remains ongoing with lvad support. 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) 2017. On (b)(6) 2018, it was reported that the patient had a rapid increase in lactate dehydrogenase to 800 u/l with concern for pump thrombosis. On (b)(6) 2018, the patient¿s inr was 4. 1. No clinical symptoms were reported. A log file was submitted for review. The manufacturer¿s technical services reviewed the provided log file which contained data from (b)(6) 2018 and observed some unsustained power and flow elevations. No other unusual events were seen within the event history and the pump appeared to be functioning as intended. Additional information was requested but not yet provided.
 
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Brand NameHEARTMATE II LVAS
Type of DeviceLEFT VENTRICULAR ASSIST DEVICE
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer Contact
bob fryc
6101 stoneridge dr.
pleasanton, CA 94588
7818528390
MDR Report Key7285745
MDR Text Key100558742
Report Number2916596-2018-00644
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2020
Device Catalogue Number106015
Other Device ID NumberN/A
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 Received01/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/05/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/21/2018 Patient Sequence Number: 1
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