MAUDE Adverse Event Report: VASCUTEK LTD Thoraflex Hybrid; Thoraflex Hybrid Plexus

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/19/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Clinical code (e): 1888 - hemorrhage/blood loss/bleeding - severe bleeding at the posterior collar anastomosis site.Impact code (f): 1802 - death - patient expired in the operating room.Medical device problem code (a): 2993 - adverse event without identified device or use problem - the thoraflex hybrid device was deployed successfully.Severe bleeding at the posterior collar anastomosis site due to poor tissue quality and challenging location to repair with suture.Component code (g): 4755 - part/component/sub-assembly term not applicable.Type of investigation (b): 4110 - trend analysis - a review of medical event > death events from jan 22 - jun 26 compared with thoraflex hybrid sales date produced an occurrence rate of (b)(4).3331 - a review of device history records from raw material to finished products will be performed in order to confirm that the device was manufactured to specification.Investigation findings (c): 3233 - results pending completion of investigation.Investigation conclusions (d): 11 - conclusion not yet available.
Event or Problem Description
Patient expired in the operating room after a successful thoraflex hybrid deployment.Severe bleeding at the posterior collar anastomosis site due to poor tissue quality (dissection/aneurysmal) and challenging location to repair with suture.Outer strip of felt used for initial collar anastomosis followed by numerous pledgets after distal re-perfusion.The chest incision was extended laterally for better aortic exposure.The patient developed a severe coagulopathy and multiple blood transfusions.The gore rep was called emergently for distal extensions, and terumo was informed the following morning that the patient expired on the operating room table.Eloped a severe coagulopathy and multiple blood transfusions.The gore rep was called emergently for distal extensions, and terumo was informed the following morning that the patient expired on the operating room table.
Event or Problem Description
Patient expired in the operating room after a successful thoraflex hybrid deployment.Severe bleeding at the posterior collar anastomosis site due to poor tissue quality (dissection/aneurysmal) and challenging location to repair with suture.Outer strip of felt used for initial collar anastomosis followed by numerous pledgets after distal re-perfusion.The chest incision was extended laterally for better aortic exposure.The patient developed a severe coagulopathy and multiple blood transfusions.The gore rep was called emergently for distal extensions, and terumo was informed the following morning that the patient expired on the operating room table.Eloped a severe coagulopathy and multiple blood transfusions.The gore rep was called emergently for distal extensions, and terumo was informed the following morning that the patient expired on the operating room table.This report is being submitted as follow up #1 for manufacturing report number 9612515-2026-00030 to provide event closure information for (b)(6).
Additional Manufacturer Narrative
Clinical code (e).1888 - hemorrhage/blood loss/bleeding - severe bleeding at the posterior collar anastomosis site.Impact code (f).1802 - death - patient expired in the operating room.Medical device problem code (a).2993 - adverse event without identified device or use problem - the thoraflex hybrid device was deployed sucessfully.Severe bleeding at the posterior collar anastomosis site due to poor tissue quality and challenging location to repair with suture.Component code (g).4755 - part/component/sub-assembly term not applicable.Type of investigation (b).4110 - trend analysis - a review of medical event > death events from (b)(6) 2022 - (b)(6) 2026 compared with thoraflex hybrid sales date produced an occurrence rate of (b)(4).3331 - a review of device history records from raw material to finished products demonstrated that no issues occurred during the manufacture of the device.Investigation findings (c).213 - no device problem found - as reported by the complainant, the patient expired perioperatively due to severe coagulopathy due to severe bleeding at the posterior collar anastomosis site due to poor tissue quality (dissection/aneurysmal) and challenging location to repair with suture.Investigation conclusions (d).4310 - cause traced to non-device related factors - as reported by the complainant, the patient expired perioperatively due to severe coagulopathy due to severe bleeding at the posterior collar anastomosis site due to poor tissue quality (dissection/aneurysmal) and challenging location to repair with suture.

• Brand Name: Thoraflex Hybrid
• Common Device Name: Thoraflex Hybrid Plexus
• 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: 25543717
• Report Number: 9612515-2026-00030
• Device Sequence Number: 10746924
• Product Code: QSK
• UDI-Device Identifier: 05037881173627
• UDI-Public: 05037881173627
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2026

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: THP3034X100E-B
• Device Lot Number: 26472679
• 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: 05/20/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/18/2026
• Supplement Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2026
• 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: Male