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U.S. Department of Health and Human Services

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

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THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM Back to Search Results
Model Number 106524
Device Problem Partial Blockage (1065)
Patient Problems Cardiac Arrest (1762); Death (1802); Thrombus (2101)
Event Date 03/28/2018
Event Type  Injury  
Manufacturer Narrative
The initial submission of this event was reported by the manufacturer under mfr. Report # 2916596-2018-01421. This report is being submitted as additional information. The heartmate 3 lvas was implanted during the momentum 3 clinical trial, ide# (b)(4). Fda approval for heartmate 3 lvas was received on 23 august 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. Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas, and the reported events could not be conclusively established through this evaluation. The heartmate 3 lvas ifu lists death as an adverse event that may be associated with the use of heartmate 3 left ventricular assist system. This document provides an explanation of all pump parameters, including pump flow, and explains that the low flow hazard alarm will be triggered when the estimated pump flow is less than 2. 5 lpm. This document and the heartmate 3 lvas patient handbook describe all alarm conditions, including the low flow hazard, as well as the appropriate actions associated with them. A review of the device history records revealed the device met applicable specifications. No further information was provided. The manufacturer is closing the file on this event.
 
Event Description
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 SYSTEM
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 95488
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 95488
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key7954471
MDR Text Key123357319
Report Number2916596-2018-04478
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2016
Device Model Number106524
Device Catalogue Number106524
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/24/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/10/2018 Patient Sequence Number: 1
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