MAUDE Adverse Event Report: Thoratec Corporation THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS); Ventricular (Assist) Bypass

Model Number	106015
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Thrombosis/Thrombus (4440)
Date of Event	08/24/2026
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 was complaining of repeated low flow alarms that did not resolve with afterload reduction.The patient presented hypertensive, upon trying to treat the hypertension the site got a computed tomography (ct) angiogram and found a large amount of peripheral thrombus within the within the outflow catheter of the left ventricle assist device with nearly 90% maximal narrowing.No significant hematoma adjacent to the assist device.Log files were sent for review.The log file was filled with low flow events.The pump appeared to be operating as intended.The device operated as expected.The event was considered therapy related as patient was hypertensive and outflow graft obstruction was discovered.Treatment included afterload reduction, ct angiography and echocardiogram.The next steps were subxiphoid window with outflow graft evacuation\ \ ct angiography findings indicated a large amount of peripheral thrombus within the within the outflow catheter of the left ventricle assist device with nearly 90% maximal narrowing.No significant hematoma adjacent to the assist device.The thoracic aorta appeared unremarkable without evidence for dissection or aneurysm.Small to moderate-sized bilateral chronic pleural effusions with pleural thickening were noted.The impression was high-grade stenosis of the outflow for the left ventricular assist device.The chronic bilateral pleural effusions appeared stable.There were no additional acute findings of the chest, abdomen or pelvis.

• Brand Name: THORATEC® HEARTMATE®, 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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; +1(781)852-8207
• MDR Report Key: 50811278
• Report Number: 2916596-2026-2919572
• Device Sequence Number: 16104876
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: (01)00813024011224(17)190930
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• 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): 09/28/2026

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 Expiration Date: 09/30/2019
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 5726609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/17/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2016
• 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: Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 198 LB