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); Failure to Power Up (1476); Decreased Pump Speed (1500); Pumping Stopped (1503); Complete Loss of Power (4015)

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

Event Date 04/11/2022

Event Type  malfunction  

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 presented to clinic for low speed hazard alarms on (b)(6) 2022.The patient had an ungrounded tether cable and history of a percutaneous lead repair in (b)(6) 2020.The system controller was replaced by the patient on (b)(6) 2022.Log files for both the primary controller and the backup controller were sent for review.The data showed multiple low speed hazards and pump stops throughout both log files which may be linked to potential issues with the percutaneous lead.Based on the patient¿s history, it looked like the short to shield repair in (b)(6) 2020 was unsuccessful.Because the low speed hazard and pump stop alarms were occurring on an ungrounded cable and batteries, it was likely that the existing short to shield had matured into a phase to phase short.The log file also captured numerous no external power alarms that appear to be related to the short.There were no other unusual events recorded in the log file event history.Since a repair had already been attempted another will not be performed.It was asked what the plan is for the patient.

Event Description

The plan for the patient was to manage the patient's heart failure without a ventricular assist device (vad).The patient's status was stable in the intensive care unit (icu), and it was also reported that the pump turned off with failure to restart.The patient's pump was turned off on (b)(6) 2022, and the patient was discharged home on dobutamine.There were no plans to remove or exchange the pump.

Manufacturer Narrative

Section b5: the patient's previous driveline repair was reported in mfr # (b)(4) manufacturer's investigation conclusion: review of the submitted log files confirmed events which appeared to be consistent with a potential issue with the driveline; however, a specific cause for these events could not be conclusively determined through this evaluation as no product was returned for investigation.Additionally, the report of the pump stopping with failure to restart could not be confirmed.A specific cause for this event could not be determined through this evaluation.The submitted log files captured multiple low speed and pump stop events on (b)(6) 2022 and (b)(6) 2022 while the patient was connected to both the power module and battery power.The log files appear to show that the pump was able to ramp back up to the set speed after each stop.The relevant sections of the device history records for (b)(6) and the driveline were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 6, ¿patient care and management¿ (under pump performance monitoring), covers wear and tear to the percutaneous lead.Section 7, ¿alarms and troubleshooting,¿ addresses all system controller alarms and how to respond to such events.The heartmate ii lvas patient handbook is also currently available.The patient handbook contains a section on ¿caring for the driveline¿; however, all heartmate ii lvas drivelines have the potential for wire/shield breakdown to occur dependent upon length of use and patient handling.The patient handbook cautions all patients to call their hospital contact if they think, for any reasons, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 14145554
• MDR Text Key: 289763506
• Report Number: 2916596-2022-10408
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2019
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2016
• 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: 41 YR
• Patient Sex: Male
• Patient Weight: 110 KG