MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSIST) BYPASS

Model Number 106015

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Hemothorax (1896); Pleural Effusion (2010); Loss of consciousness (2418)

Event Date 05/25/2022

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 the patient had a pleural effusion and underwent thoracentesis that drained 1.2 liters of fluid.Thirty minutes after the thoracentesis procedure, the patient began experiencing low flow alarms.Log files revealed a singular low flow event on (b)(6) 2022 and then starting on (b)(6) 2022 the flow dropped to below 2.4 liters per minute (lpm).The remainder of the log contained constant low flow events.A bedside echocardiogram (echo) and chest x-ray revealed a large left-sided hemothorax that was compressing the left ventricle and blocking flow through the pump.The patient went in and out of consciousness before arresting.It was confirmed there was no flow in the pump.The patient underwent an ultrasound guided thoracentesis and about 700 cubic centimeters of blood was drained.A left chest tube was placed for additional drainage.Follow up log files recorded constant low flow events leading up to and during the patient's arrest.The flow had since recovered to the 3 lpm range.As of (b)(6) 2022 the patient was awake with stable vital signs.The patient underwent thoracic surgery and had tissue plasminogen activator (tpa) injected into their chest tube on (b)(6) 2022.They still had a residual loculated hemothorax despite their chest tube.On (b)(6) 2022 the patient had been having low flow alarms throughout the night.Further log files were sent that confirmed low flow alarms due to the pump seeing a reduction in blood volume.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the log file provided by the account confirmed low flow alarms.A specific cause for these events could not be conclusively determined through this evaluation.A direct correlation between the reported events and heartmate ii left ventricular assist system (lvas), serial number (b)(6), could not be conclusively determined through this evaluation.Evaluation of the submitted log files confirmed low flow hazard alarms when the pump flow dropped below the low threshold of 2.5 lpm.A specific cause for the low flow hazard alarms could not be conclusively determined through this evaluation.No other atypical alarms were captured.The pump operated above the low speed limit for the duration of this log fie.The patient remains ongoing on the heartmate ii lvas, (b)(6).No product is available for investigation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on (b)(6) 2018.Heartmate ii lvas instructions for use (ifu) (rev.C): section 1 "introduction" provides an explanation of all pump parameters, including pump flow.Section 4 ¿system monitor¿ provides more information regarding all pump parameters and also describes situations which may result in a low flow hazard alarm, including changes in patient conditions such as hypertension.Section 4 also provides information on reviewing the event history on the system monitor.Section 6 "patient care and management" (under "pump performance monitoring") explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling, explains that pump flow is estimated from pump power, and addresses assessing pump flow.Section 6 (under "postoperative patient care") also cautions: "physiological factors that affect the filling of the pump, such as hypovolemia or postural hypotension, results in reduced pump flows as long as the condition persists.Pump flows are not restored to normal unless such conditions are treated." section 7 ¿alarms and troubleshooting¿ describes all alarm conditions, including the low flow hazard, as well as the appropriate actions associated with them.Heartmate ii lvas patient handbook (rev.C): section 5 "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.This document instructs the user that in the event of a low flow hazard alarm, call your hospital contact immediately for diagnosis and instructions.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• 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: 14688003
• MDR Text Key: 294598066
• Report Number: 2916596-2022-11333
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2021
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 6394879
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2018
• 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; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 74 KG