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 03/07/2024

Event Type  malfunction  

Event Description

It was reported that the center wanted to do an external driveline repair on (b)(6) 2024 for a patient because they had chronic driveline fault events.An or was requested to be on standby in case a pump exchange was needed.Log files from before the repair displayed multiple driveline fault alarms during the entire 29-day length of the log file history.It appeared there was a possible degraded conductor or wire connection in phase b.X-rays received were unremarkable.Per(b)(4) covers the onset of the driveline faults that started around (b)(6) 2023.At the time, a driveline repair was planned for (b)(6) 2023, but the site decided against the repair as the patient was not a candidate for pump exchange.Tech services was onsite on (b)(6) 2024 for a driveline repair.Based on log file analysis the black wire had little to no continuity triggering constant driveline fault events.The black, red, and yellow wire were spliced and when they exchanged the percutaneous lead the pump did not restart.The original percutaneous lead was plugged back in and the pump restarted.The black wire was compromised internally and tech services did not complete the repair per the centers request.Both drivelines were taped together with kapton tape and rescue tape.The patient was exchanged to a heartmate3 left ventricular assist device on (b)(6) 2024.

Manufacturer Narrative

Per(b)(4) covers the onset of the driveline faults that started around (b)(6) 2023.At the time, a driveline repair was planned for (b)(6) 2023, but the site decided against the repair as the patient was not a candidate for pump exchange.The driveline faults have continued to be monitored and reported in (b)(4).No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

• 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: 18980775
• MDR Text Key: 339776759
• Report Number: 2916596-2024-01531
• 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
• Report Date: 03/26/2024

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 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: 03/07/2024
• Initial Date FDA Received: 03/26/2024
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 115 KG