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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS

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THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 106524US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Right Ventricular Dysfunction (2054)
Event Date 07/10/2018
Event Type  Injury  
Manufacturer Narrative
The heartmate 3 left ventricular assist system (lvas) was implanted during the (b)(6)trial, ide# (b)(4). Fda approval for heartmate 3 lvas was received on 23aug2017. The gtin unique device identifier for the commercial heartmate 3 lvas is (b)(4). No further information was provided. The manufacturer is closing the file on this event.
 
Event Description
The patient's postoperative course was complicated by right ventricular dysfunction. Dopamine infusion was administered on (b)(6) 2018 and titrated down until the patient was successfully weaned off on (b)(6) 2018. A diuretic regimen was adjusted throughout the hospital course. The patient was discharged on (b)(6) 2018 on furosemide and spironolactone. No further information was reported.
 
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Brand NameHEARTMATE 3 LVAS IMPLANT KIT
Type of DeviceVENTRICULAR (ASSISST) BYPASS
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
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key10458910
MDR Text Key204518087
Report Number2916596-2020-04212
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024013297
UDI-Public00813024013297
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 health professional,study
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/13/2021
Device Model Number106524US
Device Catalogue Number106524US
Device Lot Number6491799
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 Received08/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/08/2018
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: 08/27/2020 Patient Sequence Number: 1
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