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 Pleural Effusion (2010); Heart Failure/Congestive Heart Failure (4446)

Event Date 03/24/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient was on ongoing inotropic support for 14 days post implant, indicating right heart failure.The patient remained in the cardiovascular icu (intensive care unit) on dobutamine and norepinephrine.On (b)(6) 2022, a chest x-ray performed revealed that the patient had developed a large pleural effusion; an ultrasound guided drainage was required.The patient also had elevated international normalized ratio (inr) values; a vitamin k injection was required.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct relationship between the device and the reported right heart failure, infection, and patient conditions could not be conclusively determined through this evaluation.The patient remains ongoing on ventricular assist device (vad) support with no further issues reported.Review of the device history records showed no deviations from manufacturing or qa (quality assurance) specifications.The heartmate 3 lvas instructions for use (ifu) (rev.C) is currently available.This ifu lists right heart failure, and infection as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.The ifu also provides information regarding anticoagulation, including the recommended inr values.This document also discusses the potential development of right heart failure following implant and outlines the associated treatment options.Section 1 "introduction" explains that ventricular blood may flow either through the lvad or the aortic valve to reach the aorta, the proportion of which depends greatly upon the degree of the patient's cardiac function and the set speed of the lvad.Care instructions in regard to preventing infection are included in several sections of the ifu, including in section 6 "patient care and management" (under "caution!", "caring for the driveline exit site", and "controlling infection").The heartmate 3 lvas patient handbook (rev.D) provides care instructions in regard to preventing infection in several sections, including section 4 ¿living with the heartmate 3¿ (under ¿caring for the driveline exit site¿).The patient handbook instructs the patient to call their hospital contact immediately if any signs of infection are noticed.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information: right heart failure did not exist prior to the patient's implant, but the right heart failure was not caused by a device related issue.On (b)(6) 2022, the patient's inr value became lower than anticipated; subcutaneous doses of enoxaparin were required.The patient was transferred to the hospital ward and was reportedly doing well.The patient was still on a low dose of dobutamine; the plan was to diurese the patient and slowly wean them off inotropic support.On (b)(6) 2022, the patient reportedly experienced multiple days with diarrhea; a stool culture was positive for clostridioides difficile the patient was given antibiotics and the infection resolved on (b)(6) 2022.

• 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: 13977556
• MDR Text Key: 288384280
• Report Number: 2916596-2022-10129
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/04/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8206452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 100 KG