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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 Problems Atrial Fibrillation (1729); Death (1802); Right Ventricular Dysfunction (2054); Ventricular Fibrillation (2130)
Event Date 12/07/2020
Event Type  Death  
Manufacturer Narrative
Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas, serial number (b)(4), and the reported events could not be conclusively determined through this 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 relevant sections of the device history records for the percutaneous lead were also reviewed and showed no deviations from manufacturing or quality assurance specifications. The implant kit was shipped on (b)(6) 2017. The heartmate 3 lvas ifu is currently available. This ifu lists cardiac arrhythmia and death as adverse events that may be associated with the use of heartmate 3 lvas. No further information was provided. The manufacturer is closing the file on this event.
 
Event Description
It was reported that the patient passed away due to resuscitation from arrhythmias. The patient collapsed on the street and was unconscious, resuscitated and in hospital it seemed that the patient had zero flow and an atrial fibrillation heartrate 180/min, followed by ventricular fibrillation. The right side deteriorated and decision was made to stop the pump. No autopsy was performed. The device was not explanted. The device will not be returned for evaluation.
 
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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 Key11074016
MDR Text Key223701708
Report Number2916596-2020-06253
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
P160054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2020
Device Model Number106524INT
Device Lot Number6151676
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 Received12/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/25/2017
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: 12/27/2020 Patient Sequence Number: 1
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