MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; Ventricular (assist) bypass

Model Number 106524

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

Patient Problems Bacterial Infection (1735); Fluid Discharge (2686); Skin Infection (4544)

Event Date 10/19/2023

Event Type  Injury  

Event Description

It was reported that the patient presented to the clinic with redness and drainage at the driveline exit site on (b)(6) 2023.The drainage was cultured and came back positive for pseudomonas.The patient was treated with cipro and menacycline antibiotics.The patient was followed up on (b)(6) 2023, with infectious disease doctor, and the patient's symptoms had resolved.The patient remained on the same antibiotic treatment as of (b)(6) 2024.They would continue to be monitored as outpatient.

Manufacturer Narrative

Manufacturer's 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 LEFT VENTRICULAR ASSIST SYSTEM
• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 19160000
• MDR Text Key: 340790731
• Report Number: 2916596-2024-02432
• Device Sequence Number: 1
• Product Code: DSQ
• 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
• Report Date: 04/22/2024

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: 04/24/2021
• Device Model Number: 106524
• Device Lot Number: 6572501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/16/2024
• Initial Date FDA Received: 04/22/2024
• Date Device Manufactured: 08/03/2018
• 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
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White