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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); Device Stops Intermittently (1599)
Patient Problem Thrombus (2101)
Event Date 03/30/2018
Event Type  Injury  
Manufacturer Narrative
Unique identifier (udi) #: (device identifier) - (b)(4). Approximate age of device - 1 year, 9 months. The patient remains on lvad support. No additional 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) 2016. It was reported that the patient came into the emergency department via emergency services due to battery issues. The system controller backup battery ran the lvad until the lvad system was connected to the power module in the emergency room. Pump stoppage had occurred, and pump parameters were elevated. A computed tomography of the chest was obtained which showed thrombus in the outflow graft. Approximately 17 days later, the patient was discharged home with hospice. No additional information has been 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 Key7468043
MDR Text Key106716400
Report Number2916596-2018-01520
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
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 04/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2019
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 Received04/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/10/2016
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: 04/27/2018 Patient Sequence Number: 1
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