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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

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HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 106524US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Septic Shock (2068); Cardiogenic Shock (2262); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/25/2022
Event Type  Death  
Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
It was reported the patient passed away due to septic shock, cardiogenic shock, and multiorgan failure.No additional information was reported.The onset of stroke was at time of left ventricular assist device (lvad) which was reported under (b)(4).
 
Manufacturer Narrative
The patient's stroke was reported under manufacturer report number 2916596-2021-05976.Section h6: health effect - clinical code: multiple organ dysfunction syndrome.Manufacturer's investigation conclusion.A specific cause for the reported sepsis, multiorgan failure, and subsequent patient outcome as well as a direct correlation with the device could not be determined through this evaluation.The pump was not explanted and will not be returned for evaluation.The outcome was not device related.The device operated as expected.The heartmate 3 lvas ifu, rev.C, lists death, sepsis, and various forms of organ failure as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.This ifu and the heartmate 3 lvas patient handbook both outline care instructions for preventing infection.The relevant sections of the device history records for the (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump shipped on (b)(6) 2021.No further information was provided.The manufacturer is closing the file on this event.
 
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Brand Name
HEARTMATE 3 LVAS IMPLANT KIT
Type of Device
VENTRICULAR (ASSISST) BYPASS
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key14137020
MDR Text Key289454537
Report Number2916596-2022-10448
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024013297
UDI-Public00813024013297
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,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/25/2023
Device Model Number106524US
Device Catalogue Number106524US
Device Lot Number8015339
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/15/2021
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) Life Threatening; Death;
Patient Age60 YR
Patient SexFemale
Patient Weight79 KG
Patient EthnicityNon Hispanic
Patient RaceBlack Or African American
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