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

Model Number	107801
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was reported that the patient underwent heart transplantation and pump extraction on (b)(6) 2025.The pump would return.
Event or Problem Description
The patient underwent a routine heart transplant.Regarding transplant procedures in japan, currently, there is no rule for transplant due to device malfunction or secondary factors.There had been no reports of problems with the device operating.
Additional Manufacturer Narrative
Section a2: patient age corrected.Section d4: primary udi corrected.Section d9: corrected.Manufacturer¿s investigation conclusion: evaluation of heartmate ii left ventricular assist system (lvas), serial number (b)(6) , found no device-related issues.The pump was returned assembled with the driveline severed approximately 1.5¿ from the pump housing.Distal portions of the driveline were returned measuring approximately 9.5¿ and 9.0¿.The sealed inflow conduit was returned attached to the pump inlet port.The apical sewing ring was present on the inlet extension.Approximately 0.5¿ of the sealed outflow graft was returned attached to the outflow elbow, which was returned attached to the pump outlet port.Approximately 0.5¿ of the sealed outflow graft bend relief was returned in place with the sealed outflow graft bend relief collar secured.Evaluation of the sealed inflow and outflow conduits revealed no evidence of depositions or thrombus formations that would have contributed to a flow or functional issue.Upon disassembly of the pump body, visual inspection of the pump¿s blood-contacting surfaces revealed no evidence of adhered depositions or thrombus formations.Electrical continuity testing of the returned portion of the driveline did not reveal any discontinuities or shorts.The pump underwent cleaning, reassembly, and functional testing under load conditions using a mock circulatory loop.The retrieved data revealed pump power consumption and pressure values that met manufacturing specification.The pump operated as intended.The relevant sections of the device history records for (b)(6) were reviewed and showed no relevant deviations from manufacturing or quality assurance specifications.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu), rev.A, and heartmate ii lvas patient handbook, rev.B, are currently available.No specific device-related issues or adverse events were reported in association with the routine transplant; however, the heartmate ii lvas ifu provides a list of adverse events that may be associated with the use of the heartmate ii left ventricular assist system in section 1, ¿introduction¿.The current revisions of the instructions for use (ifu) and patient handbook can also be found on the electronic ifu (eifu) page of the abbott website.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE II®, 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 22522860
• Report Number: 2916596-2025-04649
• Device Sequence Number: 8559932
• Product Code: DSQ
• UDI-Device Identifier: 00813024011996
• UDI-Public: (01)00813024011996(10)8379543(17)240322(11)220312
• 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: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2025

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: 03/22/2024
• Device Model Number: 107801
• Device Catalogue Number: 107801
• Device Lot Number: 8379543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 07/23/2025; 08/27/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/18/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2022
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 65 KG