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

Model Number 106015

Device Problems Mechanical Problem (1384); Decreased Pump Speed (1500); Pumping Stopped (1503)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2024

Event Type  malfunction  

Manufacturer Narrative

Historically related mfr 2916596-2019-03994 covering the full-length driveline replacement in the past; 2916596-2020-03532 covering short to shield.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 seen in clinic with pump stop alarms, low speed advisories, and low flow alarms.Event log files were submitted for review.The event log confirmed that pump speed dropped below the low-speed limit and captured pump stops on 07mar2024 and 08mar2024.These events occurred on battery power and appeared to be caused by a phase to phase short.It was noted that the patient had a full-length driveline replacement previously, so another driveline repair was not possible.

Event Description

It was additionally reported that the patient was unaware of the alarms.The patient had no further alarms.The patient was admitted as a status 2 candidate for a heart transplant.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the account¿s submitted log files confirmed the reported low speed alarms and pump stop events; however, a specific cause for the events could not be conclusively determined as no product was returned for evaluation.The submitted log file contained events from (b)(6) 2024 through (b)(6) 2024.A low speed and pump stop event was captured on (b)(6) 2024 which was accompanied by elevations in pump power and estimated flow, as well as a decrease in pulsatility index (pi).Based on previous complaint experience, this type of behavior captured within the submitted log file is potentially indicative of a foreign material, such as thrombus, coming in contact with the spinning rotor and creating drag.Additional pump stops were captured on (b)(6) 2024 and (b)(6) 2024 while the patient was connected to battery power; however, a specific cause for the events could not be conclusively determined.No other notable events or alarms were captured.The patient remains ongoing on heartmate (hm) ii left ventricular assist system (lvas), serial number (b)(6).No further related events have been reported at this time.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate (hm) ii left ventricular assist system (lvas) instructions for use (ifu) rev.C and the heartmate ii patient handbook rev.C are currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events, including device thrombosis, that may be associated with the use of the heartmate ii lvas.Section 1 also addresses pump parameters including pump speed, power, flow, and pulsatility index (pi).In reference to power, this section explains that pump power is a direct measurement of motor voltage and current; therefore, changes in pump speed, flow, or physiological demand can affect pump power.Gradual increases in power may signal thrombus in the pump and depending on the speed of the pump, power values greater than 10 to 12 watts also can indicate the presence of a thrombus.Additionally, lower pi values indicate less ventricular filling and lower pulsatility (ie, the pump is providing greater support and further unloading the ventricle).Under otherwise stable conditions, a significant drop in pi value may indicate a decrease in circulating blood volume.Section 6 of the ifu "patient care and management" outlines the recommended anticoagulation therapy and international normalized ratio (inr) range.This section also outlines indications of pump thrombosis, as well as how to respond to such events.Section 7 of the ifu and section 5 of the patient handbook address all system controller alarms, as well as the appropriate actions associated with them.Furthermore, these documents provide information regarding events that may cause the pump to stop and how to prevent pump stops from occurring.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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18986067
• MDR Text Key: 338699296
• Report Number: 2916596-2024-01800
• 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: 05/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2019
• Device Model Number: 106015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 05/06/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2016
• 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 Age: 46 YR
• Patient Sex: Male
• Patient Weight: 108 KG