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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 02/11/2022
Event Type  Death  
Manufacturer Narrative
Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(4) and the patient's outcome could not conclusively be established through this evaluation. (b)(4) was not returned for evaluation. The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications. The implant kit was shipped on 17apr2018. Review of the sterilization and packaging documentation in the device history records found no deviations from manufacturing specifications. The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available. Section 1 of this document lists multiple types of organ failures and dysfunctions (hepatic dysfunction, renal dysfunction, respiratory failure, and right heart failure), sepsis, and death as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system. Care instructions in regard to preventing infection are provided in various sections of the ifu, including controlling infection. The heartmate 3 lvas patient handbook is also currently available. This document contains information about preventing infection. No further information was provided. The manufacturer is closing the file on this event.
 
Event Description
It was reported that the patient passed away. The cause of death was multi-organ failure in the course of septic shock. An autopsy was not performed. 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 Key14172777
MDR Text Key289788480
Report Number2916596-2022-10368
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodePL
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 Other Health Care Professional
Type of Report Initial
Report Date 04/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2022
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 Lot Number6322082
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/09/2018
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: 04/21/2022 Patient Sequence Number: 1
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