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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 106524INT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Septic Shock (2068)
Event Date 03/19/2022
Event Type  Death  
Manufacturer Narrative
Manufacturer's investigation conclusion: a correlation between the device and the report of infection could not be conclusively determined. Infection is listed in the instructions for use as a potential adverse event that may be associated with the use of heartmate 3 left ventricular assist system. Infection has been previously investigated and will continue to be monitored through quality data reviews, which are conducted on production and post product signals to evaluate if products are conforming to product requirements. No further information was provided. The manufacturer is closing the file on this event.
 
Event Description
It was reported that the patient passed away on (b)(6) 2022 due to septic shock. It was noted that the outcome was not device related and the device operated as expected.
 
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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 Key14078612
MDR Text Key289053501
Report Number2916596-2022-01905
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P160054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/15/2022
Device Model Number106524INT
Device Lot Number7602159
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/28/2020
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: 04/11/2022 Patient Sequence Number: 1
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