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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST DEVICE

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THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST DEVICE Back to Search Results
Catalog Number 106524
Device Problem Partial Blockage (1065)
Patient Problems Cardiac Arrest (1762); Death (1802); Thrombus (2101)
Event Date 03/28/2018
Event Type  Death  
Manufacturer Narrative
The heartmate 3 lvas was implanted during the momentum 3 clinical trial, ide# (b)(4). Fda approval for heartmate 3 lvas was received on (b)(6) 2017. The same device is used commercially and in the ongoing momentum 3 trial. The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4). Approximate age of device- 1 year and 10 months. It is unknown if or when the lvad was explanted from the patient after expiration. 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) 2016. It was reported that the patient presented with low flow alarms observed on their system controller. The patient¿s spouse reported that the patient called for help then became intermittently responsive. While in the emergency room, the patient was intubated and cardiopulmonary resuscitation (cpr) was initiated. Vad flow never returned and the patient subsequently expired on (b)(6) 2018. The family does not want an autopsy. The vad clinician believes that the patient¿s death was device related. The patient was reported to have awoken from sleep and had a sudden onset of low flow alarms with flow less than 1 lpm. The lvad device was reported to be on with normal speed but almost no flow which the vad clinician hypothesize that the patient had a blockage of either inflow or outflow graft. No additional information provided.
 
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Brand NameHEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
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 Key7446004
MDR Text Key106000472
Report Number2916596-2018-01421
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 health professional,study
Reporter Occupation
Type of Report Initial
Report Date 04/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/30/2016
Device Catalogue Number106524
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 Received03/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/30/2015
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: 04/20/2018 Patient Sequence Number: 1
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