MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSIST) BYPASS

Model Number 106524US

Device Problems Pumping Stopped (1503); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Intracranial Hemorrhage (1891); Dizziness (2194); Heart Failure/Congestive Heart Failure (4446)

Event Date 03/09/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that patient with history of intracerebral hemorrhage (ich) and right ventricle (rv) failure, was admitted in the setting of recurrent pseudomonas aeruginosa requiring intravenous (iv) antibiotics.Per bedside nurse, when the patient was up to chair and flows immediately dropped to 0.0 l/min.Mean atrial pressure (map) was 90 at that time.The patient remained oriented though dizzy.They were complaining of abdominal pain.They denied any shortness of breath or chest pain.Flows persistently ranging from 0.0-0.7 for approximately 7 minutes.Patient was switched over to backup bedside monitor which confirmed low flows.Left ventricular assist device (lvad) pump was running and lvad hummed auscultated.The speed dropped from 5600 to 5300 and approximately 30 seconds later their flow was back up to 4.8 l/min.The patient remained normotensive.It was unclear about etiology of acute drop in lvad flow.Echocardiogram was planned.The patient was not on anticoagulation at the time and had rv failure requiring high-dose diuretics.The event log file captured on 09mar2024 starting at 11:57:19, low flow events.At 11:57:19 the flow dropped to.4 lpm.At 11:58:09 the flow dropped to 0 lpm.At 12:05:24 the flow recovered to 2.7 lpm.

• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18997145
• MDR Text Key: 338879786
• Report Number: 2916596-2024-01571
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/20/2023
• Device Model Number: 106524US
• Device Lot Number: 8008827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 171 KG