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

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.

• 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 Key: 14137020
• MDR Text Key: 289454537
• Report Number: 2916596-2022-10448
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/25/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8015339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/18/2022
• Supplement Dates Manufacturer Received: 04/19/2022
• Supplement Dates FDA Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Death
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American