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

Model Number 107801

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

Patient Problems Purulent Discharge (1812); Low Blood Pressure/ Hypotension (1914); Septic Shock (2068); Hemorrhagic Stroke (4417); Skin Infection (4544); Drug Resistant Bacterial Infection (4553)

Event Date 05/10/2021

Event Type  Death  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient had methicillin-resistant staphylococcus aureus (mrsa) and recurrent pseudomonas infection of the driveline exit site and chest wall as well as multiple drug-resistant organism pseudomonas bacteremia.The patient had an acute mental status change.A subdural hemorrhage and right frontal lobe intraparenchymal hemorrhage were noted.The patient developed pseudomonas septicemia with increased purulent drainage.Blood cultures taken on (b)(6) 2021 were positive for gram negative rod pseudomonas.The patient developed lactic acidosis on (b)(6) 2021.They had a supratherapeutic international normalized ratio (inr) status post vitamin k and hypotension likely related to sepsis.The patient passed away on (b)(6) 2021.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate ii left ventricular assist system (lvas), serial number (b)(6), and the reported patient outcome could not conclusively be established through this evaluation.Additionally, a specific cause for the patient's sepsis, and hemorrhagic stroke could not conclusively be determined through this evaluation.No product is available for investigation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.Review of the sterilization and packaging documentation in the device history records found no deviations from manufacturing specifications.The heartmate ii lvas instructions for use (ifu), rev.C and the heartmate ii patient handbook, rev.C are currently available.Section 1 of this ifu lists stroke, bleeding, sepsis, and death as adverse events that may be associated with the use of the heartmate ii left ventricular assist system.Section 6 outlines the suggested anticoagulation regimen and international normalized ratio (inr) range that should be maintained for patients using the heartmate ii lvas as well as the suggested anticoagulation modifications.Care instructions regarding infection are also provided in the ¿patient care and management¿ section of this ifu.The patient handbook contains care instructions for preventing infection which are outlined in various sections of this document.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II 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: 15106423
• MDR Text Key: 296621214
• Report Number: 2916596-2022-12253
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011996
• UDI-Public: 00813024011996
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/07/2022

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: 06/27/2022
• Device Model Number: 107801
• Device Catalogue Number: 107801
• Device Lot Number: 7243375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 10/06/2022
• Supplement Dates FDA Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2019
• 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): Death; Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Race: Black Or African American