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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE VENTRICULAR (ASSIST) BYPASS

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THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 105306
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Sepsis (2067); Septic Shock (2068)
Event Date 06/14/2022
Event Type  Death  
Manufacturer Narrative
No further information was provided. A supplemental report will be submitted once the manufacturer¿s investigation is completed.
 
Event Description
It was reported that the patient had multi-system organ failure and septic shock. The family decided to withdraw care and the patient passed away on (b)(6) 2022.
 
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Brand NameHEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
Type of DeviceVENTRICULAR (ASSIST) BYPASS
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key14944953
MDR Text Key295415644
Report Number2916596-2022-12104
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P060040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2016
Device Model Number105306
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2013
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: 07/07/2022 Patient Sequence Number: 1
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