MAUDE Adverse Event Report: Thoratec Corporation Thoratec® HeartMate 3® LVAS Implant Kit; Ventricular (Assist) Bypass

Model Number	106524US
Medical Device Problem Code	Electromagnetic Interference (1194)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was being worked up for a heart transplant, during which a right heart catheterization (rhc) was performed.A cardiomems (cmems) reading was attempted during the rhc but a signal was not able to be acquired in the cath lab.The representative shared an image that revealed that the sensor was rotated onto its side, roughly parallel to the spine, just above the left edge of the left ventricular assist device (lvad) and below the pacer or implantable cardioverter-defibrillator (icd).
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 3® 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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; +1(781)852-8207
• MDR Report Key: 50899825
• Report Number: 2916596-2026-2920070
• Device Sequence Number: 12262389
• Product Code: DSQ
• UDI-Device Identifier: 05415067039323
• UDI-Public: (01)05415067039323
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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 Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: L00004124
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2025
• 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: 41 YR
• Patient Sex: Female
• Patient Weight: 231 LB
• Patient Race: Black Or African American