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 01/31/2024

Event Type  malfunction  

Event Description

It was reported that the patient had an external driveline repair in (b)(6) 2023.They went into clinic recently to monitor the cable for phase c degradation.Left ventricular assist device was stable.Log files captured a few driveline fault events on (b)(6) 2024 at 18:43 and (b)(6) 2024 at 12:39 and 12:54.It appeared that the orange wire was having some intermittent continuity issues but was not broken as the events were very intermittent.The other 5 driveline wires appeared to be functioning as intended.

Manufacturer Narrative

Related event that covers the driveline repair on (b)(6) 2023 is reported under mfr#: 2916596-2023-05310.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Manufacturer Narrative

Manufacturer¿s investigation conclusion: review of the submitted log files confirmed intermittent driveline fault alarms.Although a specific cause for these alarms could not be conclusively determined through this evaluation, based on previous complaint history and similarly reported events, the driveline faults observed in the submitted log files appear to be consistent with potential driveline wire compromise.The system controller log files contained events and data from 12jan2024 through 31jan2024 and 12feb2024 through 01mar2024.Intermittent, silenced driveline fault alarms were captured on 30jan2024 and 31jan2024.Electrical continuity data recorded in the submitted log files during the driveline fault alarms revealed a continued potential wire conductor breakdown issue with the orange driveline wire in phase 3 (c).No evidence of progression in the potential driveline wire compromise was observed.Despite the observed events, the pump appeared to function as intended at the fixed speed for the duration of the file.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The patient remains ongoing on heartmate (hm) ii left ventricular assist system (lvas), serial number (b)(6), and no further related events have been reported at this time.The heartmate ii lvas instructions for use (ifu) and the heartmate ii patient handbook are currently available.Sections 6 and 8 of the hmii ifu, as well as sections 4 and 6 of the hmii patient handbook, provide information on how to care for the driveline; however, all heartmate ii lvad drivelines have the potential for wire/shield breakdown to occur dependent upon length of use and patient handling.These sections address damage due to wear and fatigue of the driveline, and outline indications of driveline damage as well as the how to respond to such events.The patient handbook also instructs the user to call their hospital contact right away if the driveline is damaged (or might be damaged).Section 7 of the hmii ifu and section 5 of the hmii patient handbook address hazard and advisory alarms, as well as how to respond to each alarm condition.Furthermore, the patient handbook contains a section on handling emergencies.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: 18740522
• MDR Text Key: 336749160
• Report Number: 2916596-2024-00770
• 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
• Type of Report: Initial
• Report Date: 02/20/2024

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 Model 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: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 86 YR
• Patient Sex: Male
• Patient Weight: 86 KG