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

Model Number 106016

Device Problems Disconnection (1171); Mechanical Problem (1384); Decreased Pump Speed (1500); Pumping Stopped (1503); Infusion or Flow Problem (2964)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 02/23/2024

Event Type  Death  

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 found expired at home and there were multiple rpm drops logged in the log file.It also looked like the batteries were drained and hence the power was no supplied.It was noted that there were some issues with the white and black cable connection.Log files were submitted for review.The log file displayed multiple low speed hazard alarms and pump stops on (b)(6) 2024 beginning around 08:28.There appeared to be a possible power issue at the system controller power leads as the system controller recorded low rsoc voltages (0 volts) at the black and white power leads while tethered on batteries.The log file recorded no external power alarms beginning on 09:00 where the black and white power leads were disconnected from batteries; the system controller operated on the backup battery at that time.It appeared the batteries were reconnected around 09:01.The low speed and pump stop events may have been related to something which may have traveled through the pump interfering with the rotor rotation.The log file recorded multiple low speed hazards / pump stops / low flow alarms, including high power events, 10.3w-25.3w, with flow 1.0 lpm - 3.0 lpm around 09:03 and with intermittent changes in pump speed, as low as 0 rpm, from 09:01 - 09:26.The patient was urgently moved to the nearest emergency room and clinicians disconnected the driveline from the system controller on (b)(6) 2024 around 09:26 when patient expiration was confirmed after arriving at the hospital; the pump stopped and was no longer powered by the system controller.Physicians wondered about the power and speed spikes after the patient's heart stopped.It was relayed that the pump could still work even if a heart stopped since fluid could be transported through the pump and the spikes were a result of the pump trying to restart.It was also noted that the physician suspected that there may have been a thrombotic event after the pump stopped.It was stated that the patient's international normalised ratio (inr) was close to 1 due to poor drug adherence.It was noted that they believed the thrombosis was located somewhere nearly, probably in the left ventricle, and it finally stuck into the pump after the drastic speed drops and increases.Conversation between abbott and the physician was still ongoing but both parties suspected that the 14v battery drainage had eventually caused the patient death; the patient had routinely been using 14v batteries although staying home and had prior drainage experiences.Related manufacturer reference number: 2916596-2024-01265 (system controller).

• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18868281
• MDR Text Key: 337248637
• Report Number: 2916596-2024-01266
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Model Number: 106016
• Device Lot Number: 6538461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2018
• 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): Death
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 65 KG