MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSIST) BYPASS

Model Number 106524US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Sepsis (2067); Hemorrhagic Stroke (4417)

Event Date 07/03/2022

Event Type  Death  

Event Description

It was reported that the patient passed away due to urosepsis and subarachnoid hemorrhage.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct cause for the patient¿s sepsis could not be conclusively determined through this evaluation.Additionally, a direct relationship between the device and the reported subarachnoid hemorrhage and patient outcome could not be conclusively determined through this evaluation.Multiple requests for additional information were issued to the customer; however, no further information was provided.The pump was not returned for evaluation.Review of the device history records showed no deviations from manufacturing or qa (quality assurance) specifications.The heartmate 3 lvas ifu is currently available.The heartmate 3 lvas ifu lists sepsis, stroke, death as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.This document provides information regarding anticoagulation, including recommended international normalized ratio (inr) values.Care instructions in regard to preventing infection are included in several sections of the ifu, including in section 6 "patient care and management" (under "caution!", "caring for the driveline exit site", and "controlling infection").Section 6 also provides suggested responses in the event of infection.The heartmate 3 lvas patient handbook provides care instructions in regard to preventing infection in several sections, including section 4 ¿living with the heartmate 3¿ (under ¿caring for the driveline exit site¿).The patient handbook instructs the patient to call their hospital contact immediately if any signs of infection are noticed 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 (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 Key: 15076491
• MDR Text Key: 296324279
• Report Number: 2916596-2022-12303
• 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: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/03/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7303276
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2019
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 89 KG