MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP; VENTRICULAR (ASSIST) BYPASS

Model Number 104911JPN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762); Hematoma (1884); Hemorrhage/Bleeding (1888); Respiratory Failure (2484)

Event Date 05/02/2022

Event Type  Death  

Event Description

It was reported that on (b)(6) 2022, the patient developed sustained ventricular arrhythmia and was admitted on (b)(6) 2022.It was reported on (b)(6) 2022, the patient developed major bleeding in the respiratory organs and respiratory failure.The pulmonary artery was damaged by the wire during cardiac catherization and the patient vomited blood; therefore, 20 to 39 ml/kg of red cell concentrate per 24 hours were transfused.The cause of bleeding was related to diagnostic procedure.During cardiac catheterization, the pulmonary artery in the right lung was damaged, causing bleeding.Bleeding was also observed in the left lung.Bronchoscopy was conducted to remove hematoma, but it was unsuccessful.On (b)(6) 2022, the patient suffered a cardiac arrest (pea: pulseless electrical activity) and left ventricular assist device (lvad) low flow alarm was confirmed.The patient was put on an ecmo (extracorporeal membrane oxygenation) due to circulation failure.As the respiratory failure and circulation failure advanced, the patient passed away on (b)(6) 2022.The cause of death was bleeding and damage to the pulmonary artery in the right lung.

Manufacturer Narrative

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

Event Description

The patient's arrhythmia required medication.Additionally, the patient was intubated for 14 days.The patient was on warfarin at the time of the event.

Manufacturer Narrative

Section e: this event occurred at (b)(6) in (b)(6), japan.Manufacturer's investigation conclusion: no device-related issues were identified through the evaluation of heartmate ii left ventricular assist system (lvas), serial number (b)(6).A direct correlation between heartmate ii lvas, serial number (b)(6), and the reported event could not conclusively be established through this evaluation.(b)(6) was returned assembled with the driveline (dl) cut approximately 2.5¿ from the pump housing and the distal portion of the dl was returned measuring approximately 35.5¿.The sealed inflow conduit (inlet tube, flex section, and inlet elbow) was returned attached to the pump¿s inlet port.The outflow elbow was returned attached to the pump's outlet port.The sealed outflow graft was returned attached to the outflow elbow.The sealed outflow graft bend relief and bend relief collar were not returned.Upon disassembly of the returned pump, coagulated, post-explanted blood was observed within the proximal side of the outlet stator.The coagulated blood appeared to have formed acutely.The coagulated blood lacked areas of lamination or denaturation, indicating that it was not present during support.Evaluation of the remaining blood-contacting surfaces did not reveal any evidence of developed depositions or thrombus formations.The pump's bearings, rotor, and blood-contacting surfaces were examined under a microscope and no anomalies related to wear or damage were observed that would have contributed to a functional issue.Electrical continuity testing of the returned portion of the driveline did not reveal any discontinuities or shorts.Functional testing of the pump under normal operating conditions revealed normal pump power consumption and pressure values comparable to the data recorded during the manufacturing process.The pump operated as intended.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) 2017.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 of this ifu lists cardiac arrhythmia, bleeding, respiratory failure, and death as adverse events that may be associated with the use of the heartmate ii left ventricular assist system.Pump speed, power, flow, and pulsatility index are also addressed in section 1 of this ifu.The ifu provides details on the factors that affect pump flow and provides information on assessing flow.The ifu explains that low flow alarms occur when the estimated flow is calculated below the low flow threshold of 2.5 liters per minute (lpm).Section 6 entitled ¿patient care and management¿ also lists arrhythmia as a potential late postimplant complication.Section 6 also outlines the suggested anticoagulation regimen and international normalized ratio (inr) range that should be maintained for patients using the heartmate ii lvas as well as the suggested anticoagulation modifications in the event there is a risk of bleeding.Lastly, the section entitled "alarms and troubleshooting" describes all alarm conditions including the low flow hazard as well as the appropriate actions associated with them.The heartmate ii lvas patient handbook, is also currently available.The ¿alarms and troubleshooting¿ section outlines all system controller alarms, including the low flow hazard alarm, and provides information regarding how to respond to and troubleshoot the alarms.The patient handbook also cautions users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP
• 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: 15046203
• MDR Text Key: 296099856
• Report Number: 2916596-2022-12266
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2019
• Device Model Number: 104911JPN
• Device Lot Number: 5832301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2017
• 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): Death; Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 46 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian