MAUDE Adverse Event Report: Vascutek LTD Thoraflex Hybrid Anteflo

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	07/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Event reported from clinical study extend - nct05639400.Type 1c endoleak, was noted intraoperatively from right renal bridging stent on (b)(6) 2026 for patient (b)(6).Treatment of the event included a vbx stent placement on (b)(6) 2026.The event was considered resolved with treatment and sequalae on (b)(6) 2026.The patient continued in the study.The investigator considered the event of type 1c endoleak as serious with moderate severity and related to the device.The site provided an update on 28 aug 26 stating that this event is related to the thoraflex hybrid procedure and related to the thoraflex hybrid device.
Additional Manufacturer Narrative
Clinical code: 4843 - clinical endoleak: site reported the event as a type1c endoleak.Impact code: 4624 - surgical intervention: the site reported that treatment of the event included a vbx stent placement on (b)(6) 2026.The event was considered resolved with treatment and sequalae on 27 july 26.The patient continued in the study.4642 - additional device required: site reported that treatment of the event included a vbx stent placement on (b)(6) 2026.Medical device code: 3190 - insufficient device problem information: awaiting further information from the site.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 > leakage > endoleak > type 1, this gave an occurrence score of 0.132%.No trend was identified requiring action at this time.3331 - analysis of production records: comprehensive batch review was performed; no issue was identified.Device was manufactured to specification.4112 - analysis of information provided by user/third part: additional information was requested, awaiting further information from the site.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusion: 11 - conclusion not yet available.22 - known inherent risk of device: review of ifu ( instruction for use) 30-213-usen rev 02 thoraflex hybrid us ifu section table 2 mentions endoleaks as potential adverse event.

• Brand Name: Thoraflex Hybrid Anteflo
• 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 business 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: 50895652
• Report Number: 9612515-2026-00061
• Device Sequence Number: 20290830
• Product Code: QSK
• UDI-Device Identifier: 05037881027081
• UDI-Public: 05037881027081
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P210006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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
• Device Expiration Date: 02/28/2026
• Device Model Number: N/A
• Device Catalogue Number: THA3240X150A-G
• Device Lot Number: 25355103
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2023
• 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
• Patient Sex: Male
• Patient Race: White