MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSISST) BYPASS

Model Number 106015

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

Patient Problems Bacterial Infection (1735); Hemolysis (1886); Unspecified Infection (1930); Right Ventricular Dysfunction (2054)

Event Date 08/20/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient was admitted on (b)(6) 2020 for leukocytosis, right ventricular dysfunction, acute kidney injury (aki), fluid overload, and elevated lactate dehydrogenase (ldh).The patient milrinone and lasix.Heparin was also started for elevated ldh.The volume status was improving, ldh was trending down, and creatine was improving.The patient's blood cultures were positive, but being repeated.Vancomycin was recommended this time.Blood cultures ruled out to be contaminated.Patient¿s renal function improved over her hospital course and was able to be taken off milrinone.Patient discharged home (b)(6) 2020.No further details were made available by the account at this time.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the device and the reported leukocytosis, right ventricular dysfunction, renal dysfunction, fluid overload, and elevated lactate dehydrogenase could not be conclusively determined through this evaluation.It was reported that the patient was admitted for leukocytosis, right ventricular (rv) dysfunction, acute kidney injury (aki), fluid overload, and elevated lactate dehydrogenase (ldh).The patient remains ongoing on heartmate ii lvas, serial number (b)(6).No product is available for investigation.The heartmate ii lvas ifu lists right heart failure, renal dysfunction, and hemolysis as adverse events that may be associated with the use of the hmii lvas.The patient care and management section of the ifu discusses anticoagulation, including recommended inr values.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump shipped on 01jun2016.The heartmate ii left ventricular assist system (hmii lvas) instructions for use (ifu) is currently available.Section 1 of this ifu lists right heart failure, renal dysfunction, and hemolysis as adverse events that may be associated with the use of the hmii lvas.The patient care and management section of the ifu discusses anticoagulation, including recommended inr values.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10661637
• MDR Text Key: 211045617
• Report Number: 2916596-2020-04856
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 83