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 Bacterial Infection (1735); Purulent Discharge (1812); Unspecified Infection (1930); Skin Infection (4544)

Event Date 03/01/2018

Event Type  Injury  

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 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.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient initially presented with bacteremia concerning for underlying driveline infection on (b)(6) 2019.On admission, patient was hemodynamically stable, afebrile with normal white blood cell (wbc) count.Computerized tomography (ct) demonstrated no evidence of fluid collection/abscess.The patient started on iv vancomycin which was transitioned to oral linezolid upon discharge on (b)(6) 2019.

Event Description

Additional information: it was reported that the patient had a chronic driveline exit site infection since 2018.Methicillin-susceptible staphylococcus aureus (mssa), group b strep, and coagulase-negative staphylococci (cons) bacteremia cultures were identified.The patient noted ongoing redness and increased drainage and was admitted for incision and drainage procedure.The patient was prescribed doxycycline as a lifelong suppressant.

Manufacturer Narrative

Section b3: conflicting information was provided by the customer regarding the onset of the patient's infection.Most recent communicated information of onset of infection stated it began in 2018.Event date was changed and estimated to reflect that.Clarification was requested but not provided.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 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: 14348208
• MDR Text Key: 291316828
• Report Number: 2916596-2022-10659
• 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: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2020
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6411973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2018
• 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): Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 73 KG