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)

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

Event Date 02/02/2024

Event Type  malfunction  

Event Description

It was reported that patient was having low speed alarm.Log files captured a number of speed-drops lower than the low-speed limit between (b)(6) 2024 and (b)(6) 2024.Tech service stated that this could be caused by a driveline short to shield since these all occurred when connected to the power module.It was advised to place the patient on an ungrounded patient cable and continue to monitor for alarms.

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 was sleeping on 14-volt batteries and a power module with a grounded patient cable with no further alarms noted.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the submitted log file confirmed intermittent low speed advisory alarms over several days between (b)(6) 2024 while the device was connected to the power module.Based on historical experience with the heartmate ii left ventricular assist system (lvas) and similar reported events, these events could be indicative of an issue with the driveline.There were no other notable alarms active in the log files.An abbott representative suggested placing the patient onto an ungrounded patient cable.It was reported that the patient was sleeping on 14-volt batteries and a power module with a grounded patient cable with no further alarms noted.Multiple requests for additional information regarding this event were submitted to the account; however, no response has been received at this time, and the patient remains ongoing on (b)(6) with no further reported issues.The relevant sections of the device history records for (b)(6) and the driveline, serial #(b)(6), were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii lvas instructions for use (ifu) rev.C is currently available.Section 6 ¿patient care and management¿ discusses damage due to wear and fatigue of the driveline.This section also contains information on ¿caring for the driveline¿ (under ¿ongoing system assessment and care¿) and provides possible indications of driveline damage as well as how to respond to such events.Section 7 "alarms and troubleshooting" outlines system controller alarms as well as how to respond to each alarm condition.Section 8 ¿equipment storage and care¿ also contains information on ¿care of the driveline,¿ and provides possible indications of driveline damage.The heartmate ii lvas patient handbook, rev.C, is also currently available.Section 4 ¿living with the heartmate ii¿ contains information on caring for the driveline.Section 5 "alarms and troubleshooting" outlines system controller alarms as well as how to respond to each alarm condition.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: 18877812
• MDR Text Key: 337650533
• Report Number: 2916596-2024-01166
• 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
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

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: 04/30/2019
• Device Model Number: 106015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2016
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 89 KG