MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSIST) BYPASS

Model Number	105903
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/22/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: a direct correlation between heartmate (hm) ii left ventricular assist system (lvas), serial number (b)(4), and the reported patient outcome could not be conclusively determined through this evaluation.It was reported that heartmate ii lvas, serial number (b)(4), was not explanted for evaluation.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii lvas instructions for use (ifu) is currently available.Section 1, ¿introduction¿, 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
The account reported that the patient expired on (b)(6) 2018.The cause of death was unknown as the patient was found deceased in bed, and an autopsy was not performed.The pump reportedly functioned as intended and the patient's outcome was not suspected to be device related.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
• 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 16243833
• Report Number: 2916596-2023-00524
• Device Sequence Number: 6409017
• Product Code: DSQ
• UDI-Device Identifier: 00813024011217
• UDI-Public: 00813024011217
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/25/2023

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: 03/31/2016
• Device Model Number: 105903
• Device Catalogue Number: 105903
• 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: 01/20/2023
• Initial Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2013
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 119 KG