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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE; VENTRICULAR (ASSIST) BYPASS

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THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE; VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 105306
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Sepsis (2067); Septic Shock (2068)
Event Date 06/14/2022
Event Type  Death  
Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
 
Event Description
It was reported that the patient had multi-system organ failure and septic shock.The family decided to withdraw care and the patient passed away on (b)(6) 2022.
 
Manufacturer Narrative
Section h6: health effect - clinical code: multiple organ dysfunction syndrome.Manufacturer's investigation conclusion: a specific cause for the patient outcome, as well as a direct correlation to heartmate (hm) ii left ventricular assist system (lvas), serial number (b)(6), could not be conclusively determined through this evaluation.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The patient passed away on (b)(6) 2022.As of 07jul 2022, the pump has not been returned.If the pump is returned to abbott at a later date, this file may be reopened to include the evaluation of the device.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.Review of the sterilization and packaging documentation in the device history records found no deviations from manufacturing specifications.The implant kit was shipped on 07aug2013.The heartmate ii lvas instructions for use (ifu) (rev.H), and the heartmate ii patient handbook (rev.G) are currently available.Section 1 of this ifu lists death, sepsis and various forms of organ failure as adverse events that may be associated with the use of the heartmate ii left ventricular assist system.Section 6 "patient care and management" outlines the recommended anticoagulation therapy and inr range.Section 6 also outlines care instructions in reference to preventing infection.No further information was provided.The manufacturer is closing the file on this event.
 
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Brand Name
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
Type of Device
VENTRICULAR (ASSIST) BYPASS
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key14944953
MDR Text Key295415644
Report Number2916596-2022-12104
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P060040
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,Followup
Report Date 07/11/2022
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? No
Device Operator Lay User/Patient
Device Expiration Date03/31/2016
Device Model Number105306
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 Received07/07/2022
Supplement Dates Manufacturer Received07/07/2022
Supplement Dates FDA Received07/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2013
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 Age43 YR
Patient SexMale
Patient Weight119 KG
Patient EthnicityNon Hispanic
Patient RaceBlack Or African American
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