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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 Problem Partial Blockage (1065)
Patient Problem Thrombus (2101)
Event Date 01/27/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Approximate age of device- 2 years and 4 months. 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) 2015. It was reported that the patient was admitted on (b)(6) 2018 due to numerous low flow alarms. The log file captured 239 low flow events in less than 4 hours duration. The low flow events persisted for 3 days. A ct scan was performed and found a large mural thrombus in the outflow graft. The pump was turned off on (b)(6) 2018 to prevent embolic shower/ stroke. The patient underwent a pump exchange to a heartmate 3. No additional information provided.
 
Manufacturer Narrative
Although the reported alarms were confirmed through evaluation of the submitted system controller log file, a specific cause for the captured events could not be conclusively determined. Additionally, the reported outflow graft thrombus could not be confirmed through this evaluation. Thrombus is listed in the instructions for use as a potential adverse event that may be associated with the use of the heartmate ii left ventricular assist system. A review of the device history records revealed that the device met applicable specifications. No further information was provided. The manufacturer is closing the file on this event.
 
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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 Key7274751
MDR Text Key100234653
Report Number2916596-2018-00597
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,Followup
Report Date 05/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2018
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 Received04/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/28/2015
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: 02/15/2018 Patient Sequence Number: 1
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