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

Model Number	103695
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2006
Type of Reportable Event	Death
Additional Manufacturer Narrative
Section b3: event date is unknown and has been estimated.Sections a and d: patient and device information is unknown.Device serial number and lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.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 previously under mfr # 2916596-2025-00764 that were concerns for needing a tougher driveline.It was noted that there were deaths in the heartmate ii trial from car door transections.The heartmate ii trial was a bridge to transplant (btt) trial.The patient's heartware was "wear" tested by slamming doors due to this event.They were noted to be much tougher compared to heartmate drivelines.Heartmate 3 was noted to be better than heartmate ii which were delicate and flimsy.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: no product was evaluated under this complaint.The heartmate ii device serial numbers, as well as other specific case/patient information, are not available.A review of the relevant sections of the device history records could not be performed as the serial number of the device was not communicated/identified.The heartmate (hm) ii left ventricular assist system (lvas) instructions for use (ifu), rev.C and the heartmate ii patient handbook rev.C are currently available.Section 1 of the ifu lists potential adverse events that may be associated with the use of the heartmate ii lvas.The patient handbook instructs the user to call their hospital contact if the patient thinks that, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.Sections 6 and 8 of the hmii ifu, as well as sections 4 and 6 of the hmii patient handbook, provide information regarding how to care for the driveline.The patient handbook also instructs the user to call their hospital contact right away if the driveline is damaged (or might be damaged).No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE II®, LVAS IMPLANT KIT, US, EP
• 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: 21752962
• Report Number: 2916596-2025-02228
• Device Sequence Number: 13176323
• Product Code: DSQ
• UDI-Device Identifier: 00813024010616
• UDI-Public: (01)00813024010616
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 103695
• Device Catalogue Number: 103695
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown