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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSIST) BYPASS

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THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 106524
Device Problems Device Difficult to Setup or Prepare (1487); Pumping Stopped (1503)
Patient Problem Cardiac Arrest (1762)
Event Date 03/26/2022
Event Type  Death  
Event Description
It was reported that the patient's wife heard the patient's device alarming in the early morning.She noted the driveline was disconnected from the controller.She tried to reconnect the driveline and struggled.Emergency medical services (ems) began cardiopulmonary resuscitation (cpr) but the patient was not able to be revived.The patient passed away due to cardiac arrest.Related manufacturer report number: 2916596-2022-12037.
 
Manufacturer Narrative
Manufacturer's investigation conclusion: the report of the driveline disconnect could not be confirmed as no log files were submitted for evaluation.A specific cause for the driveline disconnect could not be conclusively determined through this evaluation.The report of the driveline being difficult to reconnect could not be confirmed as no device was returned for evaluation.It was reported the outcome was device or therapy-related.No autopsy will be performed.The device was not explanted and will not be 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 14sep2018.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), rev.C, and the heartmate 3 patient handbook, rev d, are currently available.This ifu lists potential adverse events, including death, that may be associated with the use of the heartmate 3 left ventricular assist system.The ifu, "alarms and troubleshooting", and section 5 of the patient handbook, "alarms and troubleshooting", address all system alarm conditions as well as the appropriate actions associated with each condition.Furthermore, the patient handbook, ¿handling emergencies¿, also provides examples of emergencies and the proper actions to take in the event an emergency occurs.The heartmate 3 patient handbook, ¿how your heart pump works,¿ under sub-section titled "connecting the driveline to the system controller,") addresses the proper steps for connecting the driveline to the system controller.The heartmate 3 patient handbook section titled "emergency contact list") cautions users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.
 
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Brand Name
HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
Type of Device
VENTRICULAR (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 Key14875339
MDR Text Key295045040
Report Number2916596-2022-11834
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024013297
UDI-Public813024013297
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 Other Health Care Professional
Type of Report Initial
Report Date 06/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date05/24/2021
Device Model Number106524
Device Lot Number6626591
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/15/2022
Initial Date FDA Received06/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/08/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age75 YR
Patient SexMale
Patient Weight84 KG
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