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U.S. Department of Health and Human Services

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

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THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, EUROPE LEFT VENTRICULAR ASSIST DEVICE Back to Search Results
Catalog Number 106524INT
Device Problems Partial Blockage (1065); Material Twisted/Bent (2981)
Patient Problem Thrombus (2101)
Event Date 03/18/2018
Event Type  Injury  
Manufacturer Narrative
The patent's age, gender and weight were not provided. Fda approval for heartmate 3 lvas was received on 23 august 2017. The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4). Approximate age of device ¿ 1 year and 3 months. The device was returned for investigation. The evaluation is not yet complete. The patient remains ongoing on lvad support with the replacement device. 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 low flow alarms occurred. The patient¿s inr was 2. 6 upon admission to the hospital, and was not under 2. 0 the last three months. The patient¿s plasma free hemoglobin and lactate dehydrogenase levels were normal. There were no signs of infection. A chest ct scan showed an obstruction on the outflow graft. A pump exchange was performed on (b)(6) 2018 due to suspected pump thrombosis and possible outflow graft twisting. No additional information was provided.
 
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Brand NameHEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, EUROPE
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 Key7424678
MDR Text Key105252494
Report Number2916596-2018-01316
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeDA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2019
Device Catalogue Number106524INT
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/18/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/05/2016
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: 04/12/2018 Patient Sequence Number: 1
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