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 Abscess (1690); Bacterial Infection (1735); Pain (1994); Skin Infection (4544)

Event Date 07/15/2022

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported that on (b)(6) 2022, the patient presented to the emergency department for increased pain and drainage and was admitted on (b)(6) 2022 at 00:14.Ultrasound of soft tissue displayed an echogenic region measuring 1.1x0.7x0.5 cm which was suggestive of phlegmon or early abscess in the appropriated setting.The patient was status post failed outpatient doxycycline.Results from the wound culture revealed few staphylococcus and repeat culture showed corynebacterium.Peripherally inserted central catheter (picc) was planned and the patient was to continue daptomycin.Intravenous piggy back (ivpb)daptomycin midline catheter was to be switched to central line.Picc orders were written for outpatient parenteral antimicrobial therapy (opat) management for lvad infection secondary to the corynebacterium for four weeks.The patient was discharged earlier in the day on (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: 15122544
• MDR Text Key: 296785507
• Report Number: 2916596-2022-12577
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/16/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8358045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American