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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 Complaint, Ill-Defined (2331)
Event Date 04/01/2018
Event Type  Injury  
Manufacturer Narrative
Unique identifier (udi) #: (device identifier) - (b)(4). (b)(4) approximate age of device ¿ 4 years and 8 months.   additional information was requested, but was not 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) 2014. It was reported that low flow alarms had occurred with possible inflow or outflow obstruction. The patient had been admitted to intensive care unit (icu) and placed on multiple infusions and vasopressors. On (b)(6) 2018, it was reported that the patient was too unstable to do any further investigation of the outflow and inflow. The patient¿s atrioventricular (av) did close on (b)(6) 2018. Additional information was requested, but was not 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 Key7465586
MDR Text Key106651758
Report Number2916596-2018-01511
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 06/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2017
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 Received05/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/26/2014
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: 04/26/2018 Patient Sequence Number: 1
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