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 Atrial Fibrillation (1729); Liver Damage/Dysfunction (1954); Pulmonary Edema (2020); Thrombocytopenia (4431)

Event Date 04/29/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022 the patient had leukocytosis with no infection.The patient was also diagnosed with thrombocytopenia (not thought to be related to heparin therapy) on (b)(6) 20222 and electrocardiogram showed atrial fibrillation on (b)(6) 2022.The patient's oral intake of amiodarone was increased.The patient had a chest x-ray on (b)(6) 2022 which showed moderate pulmonary edema.They were treated with 40 mg intravenous lasix (furosemide) on (b)(6) 2022.On 2022 the patient had worsening delirium with intermittent slurring of speech.Computed tomography of the head without contract was done on (b)(6) 2022 in the setting of worsening delirium, there were no deficits, and was negative for acute processes.Panculture tests were ordered.The patient was transferred to the step down unit and was reportedly doing well and received standard care.The device was reportedly working as intended.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(4), and the reported events could not conclusively be established through this evaluation.The patient remains ongoing on heartmate 3 lvas, serial number (b)(4), and no further related events have been reported at this time.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.This ifu lists hepatic dysfunction, cardiac arrhythmia, and neurological dysfunction as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.Additionally, section 6 ¿patient care and management¿ lists arrhythmia and neurological dysfunction as potential late postimplant complications that may be associated with the use of heartmate 3 lvas.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: 14518942
• MDR Text Key: 292828254
• Report Number: 2916596-2022-10825
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/26/2022

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: Health Professional
• Device Expiration Date: 02/08/2024
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8414015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/03/2022
• Initial Date FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• 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
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White