MAUDE Adverse Event Report: Thoratec Corporation THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS); Ventricular (Assist) Bypass

Model Number	106015
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was concern for potential pump stop after the patient was placed on a mobile power unit (mpu) several times.The patient verbalized frequent alarms during the event, but the alarms were unable to be seen on routine interrogation.Upon review of the submitted log files, routine events were observed, and a pump stop was not able to be seen.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a pump stop was unable to be confirmed.The submitted log file was reviewed and captured the pump functioning as intended with no atypical alarms.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 ii left ventricular assist system (lvas), serial number (b)(6), with no further related issues 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 current revisions of the ifu and patient handbook can be found on the eifu page of the abbott website.The heartmate ii lvas ifu and the heartmate ii lvas patient handbook are currently available.The heartmate ii patient handbook section 3 ¿powering the system¿ instructs users to not connect an epc to an mpu, as the epc is not compatible.A low voltage alarm will sound if an epc is connected to an mpu.Section 7 of the ifu and section 5 of the patient handbook also address all system controller alarms, as well as the appropriate actions associated with them.Furthermore, the ifu and patient handbook provide information regarding events that may cause the pump to stop and how to prevent pump stops from occurring.The patient handbook also contains a section on handling emergencies and further instructs the user to call their hospital contact if the patient thinks that, for any reason, 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: THORATEC® HEARTMATE®, 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 ; +1(781)852-8207
• MDR Report Key: 50899451
• Report Number: 2916596-2026-2919785
• Device Sequence Number: 16130438
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: (01)00813024011224(17)160308
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 03/08/2016
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2013
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 147 LB