MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE II®, LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSIST) BYPASS

Model Number	104911JPN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	04/06/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the patient passed away due to ruptured thoracic aortic aneurysm.The death was expected since the patient did not have an intention of transplanting, the case was essentially managed as destination therapy.The device was not explanted.
Additional Manufacturer Narrative
Section d1: brand name corrected.Section d4: model and catalog numbers corrected, udi number corrected.Section e1: customer site was (b)(6).Manufacturer's investigation conclusion: a direct correlation between the heartmate ii left ventricular assist system (lvas), serial number (b)(6), and the reported patient outcome could not be conclusively determined through this evaluation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The current revision of the ifu can be found on the eifu page of the abbott website.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) is currently available.The ifu lists potential adverse events, including death, that may be associated with the use of the heartmate ii left ventricular assist system.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
Additional information was received that the aortic aneurysm was genetic in origin.There was no device involvement in the patient's death and the device operated as expected.

• Brand Name: THORATEC® HEARTMATE II®, 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 21901847
• Report Number: 2916596-2025-02524
• Device Sequence Number: 8821695
• Product Code: DSQ
• UDI-Device Identifier: 00813024011170
• UDI-Public: (01)00813024011170(10)6592956(17)210820
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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: 08/20/2021
• Device Model Number: 104911JPN
• Device Catalogue Number: 104911JPN
• Device Lot Number: 6592956
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2018
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 51 KG