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

Model Number	106015
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the log files were submitted to evaluate power spikes.It appeared there were no unusual events recorded in the log file event history.The mechanical circulatory support (mcs) equipment was operating as intended.The pump parameters trending showed power and flow trending upward with pulsatility index (pi) trending downward slightly.Per technical services, this trending could be suspect of pump thrombus.On (b)(6) 2026, the patient was admitted for elevated flows and powers (>8).Computed tomography (ct) showed narrowing of outflow graft.Upon inspection in the cardiac catheterization laboratory, narrowing and gradient were not substantial enough for team to stent the graft.During the procedure, flows and powers returned to normal, with flows in the 4 liter per minute range (lpm) and powers in 6's.Additional log files sent for review revealed that the power went down from 8.6 watts (w) to 6.1w and estimated flow from 8.6lpm to 4.5lpm on 14 jul 2026 at 15:13.Otherwise, there were no other notable alarm conditions or parameter changes in the log file.The ventricular assist device (vad) was functioning as intended.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be reported once the manufacturer¿s investigation is completed.

• 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: 50099844
• Report Number: 2916596-2026-2918655
• Device Sequence Number: 10479204
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: (01)00813024011224
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 08/13/2026

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 Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female