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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 106524INT
Device Problem Partial Blockage (1065)
Patient Problem Thrombus (2101)
Event Date 05/03/2018
Event Type  Injury  
Manufacturer Narrative
Approximate age of device ¿ 1 day. 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 heartmate 3 left ventricular assist device (lvad). It was reported that during the implant procedure, the pump was connected to the left ventricle with a clamp on the outflow graft for about 20 to 30 minutes. The patient was also supported with extracorporeal membrane oxygenation at the time while the surgeon performed the aortic anastomosis and to tunnelize the percutaneous lead. When the de-airing process was started, no flow occurred through the outflow graft. The pump and outflow graft were then removed and exchanged due to a thrombus, which had formed from the inflow to outflow graft. No further information was provided. A final report will be submitted when the manufacturer's investigation is completed.
 
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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 Key7548740
MDR Text Key109379956
Report Number2916596-2018-02019
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2020
Device Model Number106524INT
Device Catalogue Number106524INT
Device Lot Number6322082
Other Device ID Number00813024011712
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/03/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/02/2018
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: 05/29/2018 Patient Sequence Number: 1
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