MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE; VENTRICULAR (ASSIST) BYPASS

Model Number	104911
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Sepsis (2067); Tachycardia (2095)
Date of Event	02/07/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient passed away due to sepsis and ventricular tachycardia.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
Corrected data: section d4: model number and primary unique device identification (udi) number corrected.Manufacturer's investigation conclusion: a direct correlation between heartmate ii left ventricular assist system (lvas), serial number (b)(6), and the patient's outcome could not be conclusively established through this evaluation.Furthermore, a specific cause for the reported sepsis could not be determined.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no further information was provided.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 lvas ifu, rev.C and the heartmate ii lvas patient handbook, rev.C are currently available.Section 1 of the ifu lists, sepsis, cardiac arrythmia, and death as adverse events that may be associated with the use of the heartmate ii left ventricular assist system.Although only sepsis was reported by the account, several sections of the heartmate ii lvas ifu and patient handbook provide care instructions regarding how to prevent infection, as well as suggested responses in the event of infection.Section 6 of the ifu, ¿patient care and management¿, lists arrhythmia as a potential late postimplant complication.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
• 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: 21518017
• Report Number: 2916596-2025-01206
• Device Sequence Number: 8335301
• Product Code: DSQ
• UDI-Device Identifier: 00813024011170
• UDI-Public: (01)00813024011170(17)150731
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/31/2015
• Device Model Number: 104911
• Device Catalogue Number: 104911
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2013
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 130 KG