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 Dyspnea (1816); Pain (1994); Cardiogenic Shock (2262); Fluid Discharge (2686); Suicidal Ideation (4429); Heart Failure/Congestive Heart Failure (4446); Skin Infection (4544); Decreased Appetite (4569)

Event Date 06/14/2022

Event Type  Injury  

Event Description

It was reported that the patient was admitted to the hospital with symptoms of cardiogenic shock: no appetite, dyspnea, fatigue, weakness, and dizziness.The patient was started on 2.5 mcg/kg of dobutamine to return flow.Blood pressure was 101 mmhg and heart rate of 78 bpm.A chest x-ray found no congestive heart failure (chf).The patient was weaned off of dobutamine and was started on milrinone.The patient requested a "do not resuscitate" order.The patient was placed on suicide watch.The patient was seen by palliative care where they requested deactivation of their left ventricular assist device (lvad) due to pain issues and no quality of life.The patient agreed to continue with care in the hospital.The patient continued on suicide watch.The patient had suicidal ideation.A computed tomography (ct) of the patient's chest, abdomen, and pelvis, taken on (b)(6) 2022, revealed increasing subxiphoid fluid collection around the driveline.Another blood culture was performed on (b)(6) 2022 revealed negative results.On (b)(6) 2022, incision and drainage of the wound were performed and a wound vac was placed.A concern for right ventricular failure was noted.A plan was made to discharge the patient on inotropes.

Manufacturer Narrative

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

Event Description

A computed tomography (ct) of the patient's chest/abdomen/pelvis, taken on (b)(6) 2022, revealed increasing subxiphoid fluid collection around the driveline.A blood culture was performed on (b)(6) 2022 had negative results.On (b)(6) 2022, the incision and drainage of the wound were performed with a wound vac.The patient was prescribed vancomoyocin (vancocin), ceftazidime (fortaz), and fluconazole (diflucan).Cultures taken on (b)(6) 2022 grew candida albicans and vancomoyocin and ceftazidime were discontinued.Additional information revealed a concern for right ventricular failure.A plan was made to discharge the patient on inotropes.Additional information revealed that the patient's suicidal ideations came and went until the patient was discharged on (b)(6) 2022.The patient received.5 mg klonopin (clonazepam) as needed and 75mg of aripiprazole (abilify) once a day.Upon discharged, the patient made plans to follow up with behavior health and to transition into palliative care.

Event Description

Additional information revealed a concern for right ventricular failure.The patient received.5 mg klonopin as needed and 75mg of aripiprazole once a day.Upon discharge, the patient made plans to follow up with behavioral health and to transition into palliative care.The patient was discharged home on.375 mg milronone on (b)(6) 2022.The patient had moderate right ventricular dysfunction prior to implant.It was reported that the device did not contribute to the patient's right heart failure.

Manufacturer Narrative

Section a4: patient privacy laws prohibit the release of private patient information and patient date of birth should have been removed from the previous report.Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported infection, right heart failure, and patient conditions could not be conclusively determined through this investigation.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).No product is available for investigation.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), rev.C, is currently available.Section 1 of this document lists other various forms of infection and right heart failure as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Care instructions in reference to preventing infection are provided throughout this ifu, including sections titled "caring for the driveline exit site" and "controlling infection.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The lvas kit shipped on (b)(6) 2021.Review of the sterilization and packaging documentation in the device history records found no deviations from manufacturing specifications.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 (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: 14885992
• MDR Text Key: 295124108
• Report Number: 2916596-2022-11881
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8048008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2021
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 114 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American