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 10/16/2023

Event Type  malfunction  

Event Description

It was reported that, during a routine clinical visit, an interrogation of the patient's controller revealed 3 pump off alarms along with low flow alarms on (b)(6) 2023.The pump stops reportedly occurred while the patient was sleeping, and the patient denied symptoms.X-rays of the external portion of the driveline were unremarkable.The internal x-rays revealed a loop coming off the end of the pump bend relief which can stress the driveline over time.A review of the log file revealed pump speed drops and pump stop alarms on (b)(6) 2023.These issues only appear to be occurring while the vad is connected to the mobile power unit.The patient was sent home with a power module and an ungrouded patient cable.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the submitted log file confirmed events consistent with the pump struggling to maintain the fixed speed on a grounded power source.Based on prior complaint experience with the heartmate ii left ventricular assist system (lvas) and similar reported events, this behavior could be indicative of an issue with the driveline; however, a specific cause could not be conclusively determined through this evaluation.The submitted log file captured the pump struggling to maintain the fixed speed, with several motor stopped flags, and low speed advisory/hazard and low flow hazard alarms.The associated voltage levels indicated that these events occurred while the patient was supported by the mobile power unit (mpu).No other notable events or alarms were captured.The account submitted x-ray images for review showing the internal and external portions of the patient¿s driveline.A loop near the pump end bend relief and a bend in the internal portion of the driveline near the exit site were observed; however a potential wire compromise could not be confirmed based on the submitted x-ray images.The patient remains ongoing on heartmate ii lvas, serial number (b)(6), and no further events have been reported at this time.The heartmate ii (hmii) left ventricular assist system (lvas) instructions for use (ifu), rev.C, and patient handbook, rev.C, are currently available.Section 6 of the ifu entitled "patient care and management" addresses how to care for the driveline; however, all heartmate ii drivelines have the potential for wire/shield breakdown to occur dependent on duration of use and movement/flexing over time.In addition, section 6 (under "pump performance monitoring") outlines indications of driveline damage, as well as how to respond to such events.Section 7 entitled "alarms and troubleshooting" outlines system controller alarms and the appropriate actions associated with them.The heartmate ii lvas patient handbook contains a section on ¿caring for the driveline.¿ the section entitled ¿alarms and troubleshooting¿ outlines system controller alarms, as well as how to respond to each alarm condition.A section on handling emergencies is also provided.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.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient was sleeping during the events and denied any symptoms.

• 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 18174048
• MDR Text Key: 328569143
• Report Number: 2916596-2023-07847
• 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: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2020
• Device Model Number: 106015
• Device Lot Number: 6192143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2017
• 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 Age: 80 YR
• Patient Sex: Male
• Patient Weight: 79 KG