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

Model Number 106015

Device Problem Mechanical Problem (1384)

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

Event Date 01/22/2024

Event Type  malfunction  

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 log files were submitted for evaluation concerning low voltage events.The patient was having low voltage and power cable disconnects with a known tear in their driveline.The alarms were occurring while on batteries and while connected to the mobile power unit (mpu).Of note, the patients mpu was exchanged a few weeks ago due to similar alarms.X-rays were performed to check driveline integrity.The log file submitted recorded many low battery advisory events associated with atypical fluctuations in the recorded relative state of charge (rsoc) signal values of the black power cable lead while connected to battery power.This was a signal from the battery which was monitored by the system controller.There were also black power cable fault events associated with atypical fluctuations in the recorded relative state of charge (rsoc) signal values of the black power cable lead while connected to mpu power.Technical services noted that these events were indicative of an issue with the black power cable lead of the system controller.A controller exchange was recommended.The recorded data indicates that there were currently no issues with the driveline.It was noted that the x-ray images submitted were unremarkable, and there were currently no areas of concern.It was additionally communicated on 08feb2024 that a controller exchange was performed, and the alarms resolved.The patient was in stable condition at home.Related manufacturer reference number: 2916596-2024-00810 (controller).

Manufacturer Narrative

Manufacturer's investigation conclusion: evaluation of the submitted log file did not reveal any device related issues associated with heartmate ii left ventricular assist system (lvas), serial number (b)(6).The report of superficial driveline damage was previously reported under mfr# 2916596-2021-06412.The submitted log file contained events from (b)(6) 2024.No notable events or alarms associated with the pump were observed.The pump appeared to function as intended and operated at or above the low speed limit for the duration of the file.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) and driveline, serial number (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu), rev.C and the heartmate ii lvas patient handbook, rev.C are currently available.Several sections of the ifu and patient handbook, provide information regarding how to care for the driveline and address damage due to wear and fatigue of the driveline.These documents instruct the user to check their driveline daily for signs of damage, such as cuts, holes, or tears.The patient handbook also instructs the user to call their hospital contact right away if the driveline is damaged (or might be damaged).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: 18744243
• MDR Text Key: 336762281
• Report Number: 2916596-2024-00809
• Device Sequence Number: 1
• Product Code: DSQ
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2017
• Device Model Number: 106015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2014
• 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: 85 YR
• Patient Sex: Male
• Patient Weight: 51 KG