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

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.

• 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 Key: 14944953
• MDR Text Key: 295415644
• Report Number: 2916596-2022-12104
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• 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 Date: 03/31/2016
• Device Model Number: 105306
• 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 Received: 07/07/2022
• Supplement Dates Manufacturer Received: 07/07/2022
• Supplement Dates FDA Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 119 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American