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

Model Number	103695
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2006
Type of Reportable Event	Death
Event or Problem Description
It was reported that it was that a tougher driveline was needed.It was noted that there was deaths in the heartmate ii trial from car door transections.
Additional Manufacturer Narrative
Section a - specific patient information is unknown.Section d4: 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.
Additional Manufacturer Narrative
Section b: date of death was estimated as date of event.Manufacturer's investigation conclusion: it was reported by the account that a tougher driveline was needed.It was noted that in a heartmate ii bridge to transplant (btt) trial, the strength of the heartmate ii driveline was tested via car door transections.Equipment was "wear" tested by slamming in doors.It was noted that the trial resulted in deaths, and that the heartmate ii driveline was very delicate and flimsy in comparison to that of heartmate 3.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) and the heartmate ii patient handbook document 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.
Event or Problem Description
It was reported that the issue occurred more than once (mfr # 2916596-2025-02228).

• 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: 21285313
• Report Number: 2916596-2025-00764
• Device Sequence Number: 7908629
• 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): 04/03/2025

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: 01/09/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 04/03/2025
• 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