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

Model Number	104911
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Stroke/CVA (1770); Hemolysis (1886); Hematuria (2558); Thrombosis/Thrombus (4440)
Date of Event	10/06/2014
Type of Reportable Event	Death
Additional Manufacturer Narrative
G8: this report is being submitted as a correction/follow up to mfr.#2916596-2014-01974.H10: corrected to include intermacs mdum-9795 (114992).
Event or Problem Description
The patient was implanted with a left ventricular assist device (lvad).It was reported that the patient presented with elevated lactate dehydrogenase (ldh) levels, hematuria, and power elevations.Bivalirudin was initiated and the patient's numbers normalized; however, when bivalirudin was discontinued, ldh began to rise and hematuria occurred.It was reported that the surgical placement of the original pump was difficult.The pump was subsequently exchanged and the hospital reported that they plugged the old site using a felt plug and re-cored the heart.A thrombus was seen on the outflow stator blades.Additional information provided to the manufacturer indicated that the heart was re-cored because the hospital felt that the inflow was malpositioned and was potentially compromising flow.A device tracking form was received indicating that the patient expired on (b)(6) 2014 approximately 1 month after the pump exchange.The cause of death was noted to be a middle cerebral artery (mca) cerebrovascular accident (cva) due to vad thrombus.It was reported that anticoagulation likely contributed to the stroke.The second pump was reported to be functioning as intended and no device issues were reported.Additional information was received from the intermacs registry stating: power spikes, dark urine ldh elevated additional information also included indicated that the patient expired on (b)(6) 2014 due to withdrawal of support.Patient had a cva.Device function normal: yes.
Additional Manufacturer Narrative
Section h10: correction.

• 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: 21217204
• Report Number: 2916596-2025-00529
• Device Sequence Number: 14322632
• Product Code: DSQ
• UDI-Device Identifier: 00813024011170
• UDI-Public: (01)00813024011170(10)
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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: 104911
• Device Catalogue Number: 104911
• 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: 01/23/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 01/23/2025
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 105 KG