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

Model Number 100169571

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 09/23/2021

Event Type  Injury  

Event Description

It was reported that the patient had an infection of the sternal incision from their left ventricular assist device (lvad) implant.The patient had a sternal wound debridement and wound vacuum assisted closure placement.The patient was placed on oral and long term intravenous antibiotics.

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.The relevant sections of the device history records for (b)(4), including sterilization and packaging 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: 14413722
• MDR Text Key: 291816604
• Report Number: 2916596-2022-11026
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 08130240132732
• UDI-Public: 8130240132732
• 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: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/12/2022
• Device Model Number: 100169571
• Device Lot Number: 7765874
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2020
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White