MAUDE Adverse Event Report: VASCUTEK LTD THORAFLEX HYBRID ANTEFLO

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical code: 4440 - "thrombosis"/thrombus: event was reported as false lumen thrombosis.Impact code: 4625 - additional surgery: patient underwent on (b)(6) 2025, an endovascular repair of chronic residual descending dissection due to continued filling of false lumen via distal re-entry tears.4642 - additional device required: a relaypro nbs stent graft - catalogue number 28- n4-34-154-3ou, lot number: 2405300500, udi number: (b)(4).4644 - medication required: concomitant medications (taken at the time of the event) included: enalapril (ongoing) metoprolol (ongoing), warfarin was started on (b)(6) 2024 and is ongoing.Medical device problem code 2993 - adverse event without identified device or use problem: site confirmed on event intake form no device deficiency/ failures.The site also confirmed there was no device deficiency before or during implant.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: 4-year review was performed for thoraflex hybrid >occlusion/thrombosis > nature of event (false lumen) which gave an occurrence rate of (b)(4), no trend was identified requiring action at this time.4111 - communication/interview: additional information was received on 30 may 25 & 17 jun 25 which stated the below: pre/post op scans were available for review.The site confirmed the graft was oversized.The site confirmed there was no device deficiency before or during implant.The site confirmed there was no extension procedure planned for this patient.The patient did not experience d-sine the device was not implanted on a weak piece of aortic wall.The cause of leakage into the false lumen was distal re-entry tears.The reason for the distal re-entry tear was disease process.The site confirmed the implant of the relay device stopped the filling of false lumen via distal re-entry tears the ifu was followed the oversize was based on the true lumen.3331 - analysis of production records: comprehensive batch review had been performed; no issue were identified during manufacture of this device.Device manufactured to specification.4117 - device not available 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 was reported by clinical study: extend - (b)(4) on post operative day 30 (b)(6) 2024), a routine follow up cta c/a/p (the author deems this to be computed tomography angiography chest/abdomen/pelvis) reveals there was a filling of the false lumen via re-entry tears in the distal descending thoracic aorta showing a partial thrombosis of false lumen in the taa.Treatment of the event included completion endovascular stenting of the distal descending thoracic event.Patient underwent on (b)(6) 2025, an endovascular repair of chronic residual descending dissection due to continued filling of false lumen via distal re-entry tears using a relaypro nbs stent graft - catalogue number 28- n4-34-154-3ou, lot number: 2405300500, udi number: (b)(4).The patient recovered with treatment.The event was considered resolved on 26 mar 25.The patient continued in the study.Concomitant medications (taken at the time of the event) included: enalapril (ongoing) metoprolol (ongoing), warfarin was started on (b)(6) 2024 and is ongoing.
Additional Manufacturer Narrative
Clinical code: (b)(6) - thormbosis/thrombus: event was reported as false lumen thrombosis.Impact code: 4625 - additional surgery: patient underwent on (b)(6) 2025, an endovascular repair of chronic residual descending dissection due to continued filling of false lumen via distal re-entry tears 4642 - additional device required: a relaypro nbs stent graft - catalogue number (b)(4), lot number: 2405300500, udi number:(b)(4).4644 - medication required: concomitant medications (taken at the time of the event) included: enalapril (ongoing) metoprolol (ongoing), warfarin was started on (b)(6) 2024 and is ongoing.Medical device problem code 2993 - adverse event without identified device or use problem: site confirmed on event intake form no device deficiency/ failures.The site also confirmed there was no device deficiency before or during implant.Component code: 4755 - part/component/sub-assembly term not applicable type of investigation: 4110 - trend analysis: 4-year review was performed for thoraflex hybrid >occlusion/thrombosis > nature of event (false lumen) which gave an occurrence rate of (b)(4), no trend was identified requiring action at this time.4111 - communication/interview: additional information was received on 30 may 25 & 17 jun 25 which stated the below: · pre/post op scans were available for review.· the site confirmed the graft was oversized.· the site confirmed there was no device deficiency before or during implant.· the site confirmed there was no extension procedure planned for this patient.· the patient did not experience d-sine (distal stent graft new entry) · the device was not implanted on a weak piece of aortic wall.· the cause of leakage into the false lumen was distal re-entry tears.· the reason for the distal re-entry tear was disease process.· the site confirmed the implant of the relay device stopped the filling of false lumen via distal re-entry tears.· the ifu was followed.· the oversize was based on the true lumen.3331 - analysis of production records: comprehensive batch review had been performed, no issue were identified during manufacture of this device.Device manufactured to specification.4117 - device not available for testing: device remains implanted.Investigation findings: 213 - no device problem found: the objective of a thoraflex hybrid implant in a dissection case is to occlude the false lumen (promoting false lumen thrombosis).The clinician has indicated that the event was anticipated and not device or procedure related.The patient was included in the extend study suggesting distal extension future extension with a relay device was planned and was not a secondary procedure to rectify the event.Investigation conclusion: 4310 - cause traced to non-device related factors: the objective of a thoraflex hybrid implant in a dissection case is to occlude the false lumen (promoting false lumen thrombosis).The clinician has indicated that the event was anticipated and not device or procedure related.The patient was included in the extend study suggesting distal extension future extension with a relay device was planned and was not a secondary procedure to rectify the event.4323 - device problem excluded: the clinician has indicated that the event was anticipated and not device or procedure related.22 - known inherent risk of device: ifu review was performed and confirmed within thoraflex hybrid us ifu (301-213-usen) rev 2.0.Section 6 table 2 it mentions thrombosis as a potential adverse event.
Event or Problem Description
Event was reported by clinical study: extend - (b)(4).On post operative day 30 ((b)(6) 2024), a routine follow up cta c/a/p (the author deems this to be computed tomography angiography chest/abdomen/pelvis) reveals there was a filling of the false lumen via re-entry tears in the distal descending thoracic aorta showing a partial thrombosis of false lumen in the taa.Treatment of the event included completion endovascular stenting of the distal descending thoracic event.Patient underwent on (b)(6) 2025, an endovascular repair of chronic residual descending dissection due to continued filling of false lumen via distal re-entry tears using a relaypro nbs stent graft - catalogue number (b)(4), lot number: 2405300500, udi number: (b)(4).The patient recovered with treatment.The event was considered resolved on (b)(6) 2025.The patient continued in the study.Concomitant medications (taken at the time of the event) included: enalapril (ongoing) metoprolol (ongoing), warfarin was started on (b)(6) 2024 and is ongoing.This report is being submitted as follow up 1 for manufacturing report number 9612515-2025-00061 to provide event closure information for (b)(4).

• Brand Name: THORAFLEX HYBRID ANTEFLO
• Common Device Name: THORAFLEX HYBRID
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 22317726
• Report Number: 9612515-2025-00061
• Device Sequence Number: 12964940
• Product Code: QSK
• UDI-Device Identifier: 05037881026947
• UDI-Public: 05037881026947
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P210006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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: THA3034X100A
• Device Lot Number: 25192965
• 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: 05/27/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2023
• 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 Age: 48 YR
• Patient Sex: Female