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 Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Pain (1994); Skin Infection (4544)

Event Date 05/23/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported infection and bleeding event as well as a direct correlation to heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(4), could not be conclusively determined through this evaluation.The patient remains ongoing on hm3 lvas, serial number (b)(4), and no further events have been reported at this time.The heartmate 3 lvas ifu, rev.C, and the heartmate 3 patient handbook, rev.D, are currently available.Section 6 of the ifu, ¿patient care and management¿, lists infection as a potential late postimplant complication.Section 6 of the ifu, ¿patient care and management¿ (under "anticoagulation"), outlines the recommended anticoagulation regimen, including inr range for patients using the heartmate 3 lvas, as well as the suggested anticoagulation modifications in the event that there is a risk of bleeding.Several sections of the ifu and patient handbook provide care instructions regarding how to prevent infection as well as suggested responses in the event of infection.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 15apr2021.Review of the sterilization and packaging documentation in the device history records found no deviations from manufacturing specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient was admitted due to bloody grayish fluid soaking through their bandages in addition to mildly increased pain.Cultures were sent but did not show any organisms and the patient was afebrile with normal white blood cell (wbc) count.As outpatient the patient was on ctx and dalbe to be continued through (b)(6) 2022.During the admission the patient was started on vancomycin and ceftazidime.A computed tomography (ct) scan showed increased subcutaneous fluid along the course of the driveline.The patient was brought to the operating room on (b)(6) 2022 for surgical debridement, incision and draining and placement of a wound vacuum assisted closure (vac).Tissue cultures taken (b)(6) 2022 were negative and the patient remained afebrile.The patient was discharged (b)(6) 2022.

• 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: 14654314
• MDR Text Key: 294887124
• Report Number: 2916596-2022-11403
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/02/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7893382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American