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

Model Number 106524US

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

Patient Problems Pain (1994); Sepsis (2067); Septic Shock (2068); Renal Impairment (4499); Drug Resistant Bacterial Infection (4553)

Event Date 08/16/2019

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is complete.

Event Description

It was reported that the patient was admitted for (b)(6) pump infection (b)(6) 2019.The patient presented to the intensive care unit (icu) on (b)(6) 2019 with sepsis secondary to (b)(6) bacteremia.This was initially thought to be due to the patient's tunneled dialysis catheter (tdc).The patient was transferred to the floor on (b)(6) 2019, but returned to the icu on (b)(6) 2019 due to septic shock secondary to high grade (b)(6) bacteremia.The tdc was removed on (b)(6)2021, but bacteremia persisted.The patient experienced new lower back pain on (b)(6) 2019 and underwent a computed tomography scan of their lumbar spine which showed no obvious signs of osteomyelitis.A transesophageal echocardiogram was completed on (b)(6) 2019 which showed no evidence of large valvular vegetation with no visualized vegetation on the right atrial or right ventricular leads.A tagged white blood cell scan from (b)(6) 2019 showed focally increased white blood cell accumulation at the heartmate pump which was suspicious for device infection.The patient was given vancomycin with each dialysis and was determined to need vancomycin for 6 weeks since the date of the first negative blood culture on (b)(6) 2019.At that time, the patient would require hospitalization for bacteremia desensitization to be placed on lifelong prophylaxis.

Manufacturer Narrative

Manufacturer's investigation conclusion: 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 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11588992
• MDR Text Key: 243100120
• Report Number: 2916596-2021-01188
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

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: 06/05/2019
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6117128
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/30/2021
• Supplement Dates Manufacturer Received: 04/23/2021
• Supplement Dates FDA Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 41 YR
• Patient Weight: 106