MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE II®, LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSIST) BYPASS

Model Number	104911
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was reported that the patient came to the clinic with their driveline split where it meets the system controller.They denied any alarms and were feeling well.Rescue tape was applied, and it was recommended that the patient receive a clamshell repair.Log files were submitted that captured only routing events.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the separation of the controller connector bend relief was confirmed through the onsite evaluation by an abbott representative as well as the submitted photos.A specific cause for the damage could not be conclusively determined through this evaluation.Review of the submitted images showed that the driveline bend relief had separated from the metal connector.The submitted log file contained events from 13dec2025 through 15dec2025.No notable events or alarms were observed.The pump appeared to function as intended and operated at or above the lsl for the duration of the file.The patient remains ongoing on heartmate ii left ventricular assist system, serial number (b)(6), and no further related events have been reported.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.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) rev.B, and the heartmate ii lvas patient handbook, rev.A, are currently available.The ifu and patient handbook, provide information regarding how to care for the driveline and address damage due to wear and fatigue of the driveline.These documents instruct the user to check their driveline daily for signs of damage, such as cuts, holes, or tears.The patient handbook also instructs the user to call their hospital contact right away if the driveline is damaged (or might be damaged).The current revision of the ifu and patient handbook can be found on the eifu page of the abbott website.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that a clamshell repair was performed with no issues.

• Brand Name: THORATEC® HEARTMATE II®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Common Device Name: 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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 23950054
• Report Number: 2916596-2025-08189
• Device Sequence Number: 10683841
• Product Code: DSQ
• UDI-Device Identifier: 00813024011170
• UDI-Public: (01)00813024011170(17)150731
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/31/2015
• Device Model Number: 104911
• Device Catalogue Number: 104911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 107 KG