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 Unspecified Infection (1930); Pleural Effusion (2010)

Event Date 06/13/2022

Event Type  Injury  

Event Description

It was reported that the patient had an elevated white blood cell count at 17 and required 8 liters of oxygen and was started on cefepime.A computed tomography of the chest was performed and showed left pleural effusion and interstitial infiltrates.The infection resolved on (b)(6) 2022.

Manufacturer Narrative

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

Manufacturer Narrative

Section a2: patient date of birth was inadvertently added in initial report and should have been removed due to patient privacy laws.Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported events 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 remains ongoing on heartmate 3 lvas, serial number (b)(6), with no further related issues reported at this time.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), document #100169835, rev.C, and the heartmate 3 lvas patient handbook, rev.D, are currently available.Section 1 of the ifu, ¿introduction¿, lists infection as an adverse event that may be associated with the use of heartmate 3 lvas.Section 6 of the ifu, ¿patient care and management¿, provides care instructions in reference to preventing infection.Additionally, this document provides suggested responses in the event of infection.Furthermore, the heartmate 3 lvas patient handbook provides care instructions in regard to preventing infection in several sections.The relevant sections of the device history records for (b)(6) including packaging and sterilization records, were reviewed and showed no deviations from manufacturing or quality assurance specification.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 G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15029828
• MDR Text Key: 295987939
• Report Number: 2916596-2022-12079
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/23/2024
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8468618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American