MAUDE Adverse Event Report: Vascutek LTD Thoraflex Hybrid Plexus

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aortic dissection (4870)
Date of Event	03/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical code 4870 - aortic dissection: event was reported from the site as dsine.(distal stent graft-induced new entry) impact code 4625 - additional surgery: treatment of this ae (adverse event) included reintervention, tevar( thoracic endovascular aneurysm repair) -implantation on (b)(6) 2022.The event was considered resolved on (b)(6) 2022 and the patient continued in the study.Medical device problem 2993 - adverse event without identified device or use problem.Component code 4755 - part/component/sub-assembly term not applicable.Type of investigation 4110 - trend analysis: four-year review was performed for thoraflex hybrid > medical event > dsine & nature of event: dsine, this gave an occurrence rate of (b)(4).Increasing trend was identified and further review is being performed with sme (subject matter experts) to identify any further required actions.4111 - communication/interviews: awaiting further information from the site.3331 - analysis of production records: still to be performed, results will be added to next report 4112 - analysis of information provided by user/third party: awaiting further information from the site 4117 - device not accessible for testing: device remains implanted.Investigation findings 3233 - results pending completion of investigation.Investigation conclusion 11 - conclusion not yet available.
Event or Problem Description
Event reported by thor - (b)(4).Patient (b)(6), a white male with aortic chronic dissection, experienced an event of dsine (distal stent graft induced new entry).The patient underwent an open surgical replacement of the aorta with a thoraflex hybrid plexus device on (b)(6) 2021.On post operative day 369 ((b)(6)2022), patient (b)(6) had an ae (adverse event) of dsine (on ct scan from (b)(6) 2022 was a dsine detectable).Treatment of this ae included reintervention, tevar (thoracic endovascular aortic repair) -implantation on (b)(6) 2022.The ae was considered resolved on (b)(6) 2022 and the patient continued in the study.
Event or Problem Description
Event reported by (b)(6).Patient (b)(6), a white male with aortic chronic dissection, experienced an event of dsine(distal stent graft induced new entry).The patient underwent an open surgical replacement of the aorta with a thoraflex hybrid plexus device on (b)(6) 2021.On post operative day 369 ((b)(6) 2022), patient (b)(6) had an ae (adverse event) of dsine (on ct scan from (b)(6) 2022 was a dsine detectable).Treatment of this ae included reintervention, tevar (thoracic endovascular aortic repair) -implantation on (b)(6) 2022.The ae was considered resolved on (b)(6) 2022 and the patient continued in the study.This report is being submitted as follow up to provide event closure information for (b)(4).
Additional Manufacturer Narrative
Clinical code: 4870 - aortic dissection: event was reported from the site as dsine (distal stent graft-induced new entry).Impact code: 4625 - additional surgery: treatment of this ae (adverse event) included reintervention, tevar (thoracic endovascular aneurysm repair) -implantation on (b)(6) 2022.The event was considered resolved on (b)(6) 2022 and the patient continued in the study.Medical device problem: 2993 - adverse event without identified device or use problem.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 > medical event > dsine & nature of event: dsine, this gave an occurrence rate of 0.050%.Increasing trend was identified and further review is being performed with sme (subject matter experts) to identify any further required actions.3331 - analysis of production records: comprehensive batch review was performed, no issues were identified and the device was manufactured to specification 4112 - analysis of information provided by user/third party: additional information was provided by the site which stated the below: the approximate diameter of the true lumen at the distal landing zone is 28.5mm.The intention was to only to seal and not to remodel the true lumen back to the vessel's original diameter only to seal.There was no significant curvature of the aorta in the distal landing zone.No issues with the device before or during implantation.The device was deployed into a dissected aorta.There was no oversizing, under sizing 24mm fet vs.28.5mm aorta.The patient had a stent graft extension via tevar.The patient status is deceased on (b)(6) 2023, cause of death was severe infective endocarditis.Scan review was performed on (b)(6) 2026 which concluded the below: a thoraflex hybrid device has been implanted to exclude an aortic dissection entry tear within the aortic arch.On 49 days post-op imaging, there is evidence of contrast external to the graft within the aortic arch.The origin of this is unclear, although appears to come from near the proximal end of the stented segment.On 369 days post-op imaging, the presence of the contrast external to the graft remains.Although difficult to identify with absolute certainty, there is a potential source is between the first and second ring stents on the patient's left side.If this is the source this would represent a type 3 endoleak.This could represent a graft defect or tear caused during the implant procedure.On all imaging there is no evidence of dsine, the original adverse event reported.The device relationship was undetermined for this event.Investigation findings: 213 - no device problem found: based on the additional site information, scan review findings, and manufacturing assessment, the reported dsine could not be substantiated.Imaging review identified no evidence of dsine on any available scans; however, persistent contrast external to the graft was observed and was considered most consistent with a potential type iii endoleak originating near the proximal stented segment.The exact source could not be determined and may represent either a graft defect or procedural-related damage sustained during implantation.The device was implanted in a dissected aorta without reported sizing, deployment, or performance issues, and a comprehensive batch review confirmed the device was manufactured to specification with no identified manufacturing anomalies.Therefore, the relationship between the device and the reported event remains undetermined.Investigation conclusion: 67 - no problem detected: based on the additional site information, scan review findings, and manufacturing assessment, the reported dsine could not be substantiated.Imaging review identified no evidence of dsine on any available scans; however, persistent contrast external to the graft was observed and was considered most consistent with a potential type iii endoleak originating near the proximal stented segment.The exact source could not be determined and may represent either a graft defect or procedural-related damage sustained during implantation.The device was implanted in a dissected aorta without reported sizing, deployment, or performance issues, and a comprehensive batch review confirmed the device was manufactured to specification with no identified manufacturing anomalies.Therefore, the relationship between the device and the reported event remains undetermined.

• Brand Name: Thoraflex Hybrid Plexus
• 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: 25835011
• Report Number: 9612515-2026-00038
• Device Sequence Number: 9477454
• Product Code: QSK
• UDI-Device Identifier: 05037881031712
• UDI-Public: 05037881031712
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P210006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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 Expiration Date: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: THP2224X100B-G
• Device Lot Number: 18450875
• 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: 07/18/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 07/16/2026
• Supplement Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2020
• 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; Required Intervention
• Patient Sex: Male
• Patient Race: White