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U.S. Department of Health and Human Services

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

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THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 106524US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pleural Effusion (2010); Vomiting (2144); Ascites (2596); Renal Impairment (4499)
Event Date 05/08/2021
Event Type  Death  
Event Description
It was reported that the patient passed away on (b)(6) 2021 due to a failure to thrive. Additional details leading up to the patient's death were determined to be intermacs (interagency registry for mechanically assisted circulatory support) 1, intermittent dialysis, pleural effusions, ascites requiring multiple thoracentesis, poor intake which required a peg (percutaneous endoscopic gastrostomy) tube placement. The patient redeveloped ascites, 6 l removed. The patient also vomited during physical therapy with decreased levels of consciousness. The patient wished to go home and the family decided on hospice. The patient passed away shortly after.
 
Manufacturer Narrative
Manufacturer's investigation conclusion: a direct relationship between heartmate 3 left ventricular assist system (lvas), serial number (b)(4), and the reported events and patient outcome could not be conclusively determined through this evaluation. The device was not explanted 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 heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available. This ifu lists renal dysfunction and death as adverse events that may be associated with the use of heartmate 3 left ventricular assist system. No further information was provided. The manufacturer is closing the file on this event.
 
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Brand NameHEARTMATE 3 LVAS IMPLANT KIT
Type of DeviceVENTRICULAR (ASSIST) 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 Key15065587
MDR Text Key296230952
Report Number2916596-2022-12281
Device Sequence Number1
Product Code DSQ
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,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number106524US
Device Catalogue Number106524US
Device Lot Number7675311
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 Manufactured09/28/2020
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: 07/20/2022 Patient Sequence Number: 1
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