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

Model Number 106524US

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

Patient Problems Bacterial Infection (1735); Purulent Discharge (1812); Pleural Effusion (2010); Cough (4457)

Event Date 11/08/2021

Event Type  Injury  

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 that the patient presented to the emergency department with a cough and complaint of shortness of breath.Leukocytosis noted and left pleural effusion per x-ray.The patient was diagnosed with methicillin-susceptible staphylococcus aureus (mssa) bacteremia and mssa empyema.The patient underwent a surgical debridement of sternal wound and removal of broken sternal wire as well as drainage of left lower lobe empyema.Both occurred during the same admission.The reported event has a start date of (b)(6) 2021 and resolved with sequelae however effusions remain and were stable at discharge on (b)(6) 2021.

Manufacturer Narrative

G2: company representative was selected inadvertently.Manufactures investigation conclusion: the pump remains in use supporting the patient.A correlation between the device and the report of infection could not be conclusively determined.Infection is listed in the instructions for use as a potential adverse event that may be associated with the use of heartmate 3 left ventricular assist system.Infection has been previously investigated and will continue to be monitored through quality data reviews, which are conducted on production and post product signals to evaluate if products are conforming to product requirements.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 (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: 13635596
• MDR Text Key: 287926291
• Report Number: 2916596-2022-00987
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/17/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8017291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 122 KG