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

Model Number	107801
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Stenosis (2263); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a4: patient weight was requested but not yet provided by the hospital.Section d4: the expiration and manufacturing date was not determined and will be available after the manufacturer¿s investigation is complete.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 had a narrowing of the outflow graft.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported narrowing of the outflow graft could not be confirmed through this evaluation.Multiple attempts were made to obtain additional information regarding the reported event; however, no further information was provided by the customer.The patient remains ongoing on heartmate ii left ventricular assist system, serial number (b)(6).No further related events have been reported at this time.The relevant sections of the device history records for (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 is currently available.Section 5 of the ifu, ¿surgical procedures¿, outlines considerations for pump placement and provides instructions regarding the preparation, installation, and orientation of the sealed outflow graft.This section instructs the user to verify that the graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief and ensuring that the line is straight.Additionally, this section cautions that the sealed outflow graft must not be kinked or positioned where it could abrade against a pump component or body structure.The current revision of the ifu 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.

• Brand Name: THORATEC® HEARTMATE II®, LVAS IMPLANT KIT
• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 23383232
• Report Number: 2916596-2025-06871
• Device Sequence Number: 18322375
• Product Code: DSQ
• UDI-Device Identifier: 00813024011996
• UDI-Public: (01)00813024011996(17)180531
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2018
• Device Model Number: 107801
• Device Catalogue Number: 107801
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2015
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Male