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); Decreased Pump Speed (1500); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the ventricular assist device (vad) coordinator saw one power spike and 2 low flows on left ventricular assist device (lvad) interrogation.The site was also inquiring if the patient would benefit from a clamshell repair.Log file review was requested which captured low flow alarms on (b)(6) 2026.The log file also captured transient power and flow elevations on (b)(6)2026.No other unusual events were noted.A slight tear to the driveline was also noted.The driveline appeared well covered with rescue tape and a clamshell repair would be scheduled in around a week.The patient was seen in clinic on (b)(6) 2026 with high flow and power beginning (b)(6) 2026.No alarms were reported, however occasional low voltage advisory alarms were noted.A low-speed advisory was captured on (b)(6) 2026 while on mobile power unit (mpu) power.Speed was noted at 8120 rpm with a low-speed limit of 8400 rpm.A upward shift in pump power (b)(6)2026 at 11:36 with powers noted in the 6-7w range, the patient¿s baseline was around 4w.The patient's lab values were pending, and the patient had symptoms of dizziness with position changes.The patient had a hospitalization the week of (b)(6) 2026 for external outflow graft obstruction (eogo) identified with ct with contrast which caused the low flow events.Intervention for the eogo was performed, they patient was awaiting outflow graft stenting.The patient was not on any anticoagulants as of 2017 status post intracranial hemorrhage.The patient remained admitted for further evaluation.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when 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: 50131426
• Report Number: 2916596-2026-2918711
• Device Sequence Number: 13390302
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: (01)00813024011224(17)200831
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2026

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: 08/31/2020
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 6147254
• 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: 07/20/2026
• Supplement Date Received by Manufacturer: 08/04/2026; 09/01/2026
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 08/26/2026; 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FA-Q124-HF-1
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 138 LB