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 Code	Gastrointestinal Hemorrhage (4476)
Date of Event	10/28/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: a correlation between the device and the report of gastrointestinal (gi) bleeding could not be conclusively determined.Bleeding is listed in the instructions for use as a potential adverse event that may be associated with the use of heartmate 3 left ventricular assist system.Gi bleeding has been previously investigated and will continue to be monitored through quality data reviews, which are conducted on production and post product signals to evaluate if products are conforming to product requirements.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that the patient was admitted on (b)(6) 2025 to (b)(6) 2025 with gastrointestinal bleeding (gib).Esophagogastroduodenoscopy (egd)/colonoscopy was unable to find the source, but hemoglobin continued to trend downward even with blood transfusions.The patient passed away at home while on hospice on (b)(6) 2025 at 14:05.The outcome was not considered to be device related.The outcome was related to gib secondary to anticoagulation and ventricular assist device (vad) support.The device parameters were within normal limits for this patient.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

• 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: 23759662
• Report Number: 2916596-2025-07903
• Device Sequence Number: 21365067
• Product Code: DSQ
• UDI-Device Identifier: 00813024011170
• UDI-Public: (01)00813024011170(17)140131
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: 01/31/2014
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2012
• 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: 86 YR
• Patient Sex: Male
• Patient Weight: 61 KG