MAUDE Adverse Event Report: Vascutek LTD Thoraflex Hybrid Ante-Flo

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Event reported as thrombus distal thrombus inside the stent at the junction of the graft.One day following the initial procedure, the patient was placed on aspirin and had a ct(computed tomography) scan with the vascular surgeons as part of a follow-up for tevar(thoracic endovascular aortic repair).Thombus identified on transoesophageal echocardiography (toe).The treating vascular surgeon reported that the thoracic stent graft was appropriately deployed and fully expanded.6hr bypass time, blood transfusion given but no excessive products given.No death/serious injury.No surgical intervention.Sales associate has requested patient condition follow up report.
Additional Manufacturer Narrative
Clinical code 4440 - thrombosis/thrombus: event reported as thrombosis.Impact code 4644 - medication required - the site reported that the patient was placed on aspirin.The stent graft was reported by the treating surgeon to be appropriately deployed and fully expanded.Medical device problem 3190 - insufficient device problem information: awaiting further information.Component code 4755 - part/component/sub-assembly term not applicable.Type of investigation 4109 - historical data analysis: four-year review was performed for thoraflex hybrid > occlusion/thrombosis > body/unknown/blank jan22 - aug26 which gave an occurrence score of 0.116%.Investigation finding 3233 - results pending completion of investigation.Investigation conclusion 11 - conclusion not yet available.

• Brand Name: Thoraflex Hybrid Ante-Flo
• Common Device Name: Thoraflex Hybrid
• Manufacturer (Section D): Vascutek LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA49R R; UK PA49RR
• Manufacturer (Section G): Vascutek LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA49R R; UK PA49RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA49R-R ; UK PA49RR
• MDR Report Key: 50685343
• Report Number: 9612515-2026-00059
• Device Sequence Number: 20162561
• Product Code: QSK
• UDI-Device Identifier: 05037881031989
• UDI-Public: 05037881031989
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P210006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: THA3038X100B-G
• Device Lot Number: 26057304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2025
• 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: Other
• Patient Sex: Unknown