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 Arrhythmia (1721); Intracranial Hemorrhage (1891); Liver Damage/Dysfunction (1954); Septic Shock (2068); Fungal Infection (2419); Respiratory Failure (2484); Hemorrhagic Stroke (4417)

Event Date 08/15/2021

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2021, the patient developed an intracranial bleed and had a brain stroke (aphasia) diagnosed via computed tomography (ct).The patient was on wafarin and aspirin at the time of the event.The patient had anti-seizure drugs.The patient had been administered warfarin and international normalized ratio (inr) was longer in the target range.On (b)(6) 2021, the patient experienced fungal infection, positive blood cultures.The patient received drug therapy.The infection was determined to be due to complexities of medical management and it was not related to the pump.On (b)(6) 2021, the patient developed respiratory failure.The patient was intubated for 5 days.The respiratory failure was caused by septic shock.On (b)(6) 2021, the patient experienced fungal infection, neurological dysfunction, and sustained ventricular arrhythmia which needed cardioversion or defibrillation.The infection was from the outflow graft to the aorta anastomotic site.Medication was administered.The infection was due to complexities of medical management and disseminated candida septicemia.The intercranial bleed was in the left hemisphere of the brain and was diagnosed via computed tomography.Medication was administered.The brain stroke was due to complexities of medical management.The patient experienced cardiac arrhythmia which was determined to be due to the patient's deteriorating general condition.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate (hm) 3 left ventricular assist system (lvas), serial number: (b)(6), and the reported events could not be conclusively determined through this evaluation.The account reported that on (b)(6) 2021, the patient was admitted for aphasia, which lasted over 24 hours.A computed tomography (ct) scan was taken which revealed an intracranial bleed.The patient had been on warfarin and aspirin at the time of the event and the patient¿s international normalized ratio (inr) was noted to be longer than the target range.No surgical procedures were performed, and the patient was given anti-seizure medication.While admitted, the patient was found to have a fungal infection, with positive blood cultures on (b)(6) 2021.The patient was treated with drug therapy only.On (b)(6) 2021, the patient developed hepatic dysfunction with elevated bilirubin, aspartate aminotransferase (ast), and alanine aminotransferase (alt) levels.The hepatic dysfunction was determined to be caused by the patient¿s congested liver.On (b)(6) 2021, the patient developed respiratory failure due to septic shock which required intubation for 5 days.Later, on (b)(6) 2021, the patient showed further signs of fungal infection and neurological dysfunction.The infection site was located from the outflow graft to the aortic anastomosis and the patient was treated again with drug therapy.The infection was determined to be caused by medical management complexities and disseminated candida septicemia.The neurological dysfunction was evidenced by the patient¿s decreased level of consciousness and lasted over 24 hours.An additional ct scan was taken which revealed an intracranial bleed in the left hemisphere of the brain.The patient was on heparin at the time of the event.No surgical procedure was required, and the patient was treated with medication.The stroke was determined to be caused by medical management complexities.The patient also suffered sustained ventricular arrhythmia due to a deteriorating general condition and required cardioversion or defibrillation.Information later received stated that the hospital was contacted multiple times; however, no further information related to the events would be provided.The patient remained ongoing on heartmate 3 lvas, serial number: (b)(6), until on (b)(6) 2022 when the patient ultimately expired due to sepsis (related manufacturer report number 2916596-2022-11520).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 implant kit was shipped on 08mar2020.The heartmate 3 lvas instructions for use (ifu) and the heartmate 3 patient handbook are currently available.The ifu lists bleeding, cardiac arrhythmia, infection (local, driveline, pump pocket), respiratory failure, sepsis, stroke, and hepatic dysfunction as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.This document also lists infection and arrhythmia as potential late postimplant complications.The ifu also provides information regarding the recommended anticoagulation regimen, including inr range, as well as suggested anticoagulation modifications.Furthermore, several sections of the ifu and patient handbook provide care instructions regarding how to prevent infection as well as suggested responses in the event of infection.No further information was provided.The manufacturer is closing the file on this event.

Event Description

On (b)(6) 2021, the patient developed hepatic dysfunction with elevated bilirubin, aspartate aminotransferase (ast), and alanine aminotransferase (alt) levels.The hepatic dysfunction was reportedly not related to the device and determined to be caused by the patient¿s congested liver.

• 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: 14702385
• MDR Text Key: 294597763
• Report Number: 2916596-2022-11746
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/17/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7397109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2020
• 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): Required Intervention; Hospitalization
• Patient Age: 27 YR
• Patient Sex: Male
• Patient Weight: 62 KG