MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC HEARTMATE 3 LVAD; VENTRICULAR (ASSISST) BYPASS

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

Patient Problems Bacterial Infection (1735); Septic Shock (2068)

Event Date 07/15/2021

Event Type  Injury  

Event Description

Heartmate 3 left ventricular assist device (lvad) was admitted with the fourth hospitalization for lvad-related infection with relapse bacteremia and septic shock.The patient required vasopressors and intensive care unit level of care, only 2 weeks after previous iv antibiotic course ended.Culture confirmed the current isolate was sensitive to zosyn, so patient was discharged after 2 week hospitalization with planned iv antibiotic course.No surgery required during this hospitalization.Patient is not a candidate for lvad exchange due to high risk.Goals of care discussions initiated, and patient desire all interventions/measures possible to extend life.

• Brand Name: THORATEC HEARTMATE 3 LVAD
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 12505488
• MDR Text Key: 272464140
• Report Number: 12505488
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2021
• Device Age: 32 MO
• Event Location: Home
• Date Report to Manufacturer: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 25550 DA
• Patient Weight: 92