MAUDE Adverse Event Report: VASCUTEK LTD THORAFLEX HYBRID; THORAFLEX HYBRID ANTE-FLO

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Coronary obstruction/occlusion (4871)
Date of Event	10/01/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Manufacturer narrative: clinical code: 4871 - coronary obstruction/occlusion - event of arterial clots reported from extend post market study.Impact code: 4648 - insufficient information - patient outcome ongoing / unresolved still treating.Device problem code : 3190 - insufficient information - no device deficiency has been communicated.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: a 4 year similar event review thoraflex hybrid sales (b)(6) 2021 -(b)(6) 2024 vs occlusion/ thromobosis > artery events jan 21 - jan 25 gave an (b)(4).Actions will be taken on this trend.4111 - communication interview: additional information.3331 - analysis of production records: full batch review will be performed.4117 - device not returned: device remains implanted.Investigation findings: 3233 - results pending completion of investigation-investigation is ongoing and results are not yet available.Investigation conclusion: 11 - conclusion not yet available -a conclusion has yet to be established as the investigation is incomplete.
Event or Problem Description
Implant date : (b)(6) 2023.Event was reported from extend post market study (b)(6)) as arterial clots.
Additional Manufacturer Narrative
Clinical code: 4871 - coronary obstruction/occlusion - event of arterial clots reported from extend post market study.Impact code: 1802 - death: the site confirmed on (b)(6) 2025, the patient died due to septic shock.Device problem code: 2993 - adverse event without identified device or use problem - the site reported data indicates no device defects before use and no issues during device implant.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: a 4 year similar event review thoraflex hybrid sales (b)(6) 2021 - (b)(6) 2024 vs occlusion/ thrombosis > artery events (b)(6) 2021 - (b)(6) 2025 gave an occurrence rate of (b)(4).Actions will be taken on this trend.4111 - communication interview: additional information was receive from the site confirmed the below: · the ae changed from arterial clots to deep vein thrombosis.· the site reported data indicates no events related to patients artery damage during implant.· there was no calcification in the artery.· the site reported data indicates no device defects before use.· the patient medical history confirmed atrial fibrillation · the patient died due to septic shock.· the patient had an aneurysm of popliteal artery prior to implant of thoraflex hybrid.Additionally page 41 also confirmed post operative "right superficial femoral artery occlusion" onset 04oct2023, requiring anticoagulant therapy (remained unresolved at time of death).· indicates distal seal was obtained at the end of procedure however, the attached medical notes indicated ct findings (from (b)(6)2023) as ".Unclear if this is type 2 retrograde from the left subclavian artery or a type 1 from an unsealed end of graft, however, maximal axial dimension of the aneurysm itself was unchanged at 74, compared to 70mm previously." confirming site were aware.· confirms cause of death was septic shock, also further confirms sequence of events and preliminary cod (cause of death) as septic shock.3331 - analysis of production records: comprehensive batch review was performed, no issues identified during manufacturing process.Device was manufactured to specification.No causal link between the device and event was identified.4117 - device not returned: device remains implanted.4112 - analysis of information provided by user/third party: scan review was performed (b)(6) 2025, this review concluded: · a thoraflex hybrid device was implanted to treat an aneurysm of the distal arch and proximal descending aorta.The device was implanted with a suture collar attachment site in zone 0/1.The stented section of the thoraflex hybrid device is not obtaining a distal seal and is located within the aneurysm sac.A single branch has been used to reconstruct the bct and lcca, with the lsa being over stented but remaining patent due to retrograde perfusion.· the thoracoabdominal aorta is ectatic, with a notable region of thrombus at the level of the sma.There is an indwelling evar device, which is fully patent.Distally, the right superficial femoral and popliteal arteries are occluded, as is the left popliteal artery.It is unclear if this condition was present pre implant of the thoraflex hybrid device.· assessment of the imaging confirms the thoraflex hybrid device is performing as intended, albeit a distal seal is not achieved however as this case is part of the extend study, future distal extension is anticipated.This event is therefore likely to be procedure related.Investigation findings: 213 - no device problem found: comprehensive batch review was performed, no issues identified during manufacturing process.Device was manufactured to specification.No causal link between the device and event was identified.The site reported data indicates no device defects before use and no issues during device implant.Investigation conclusion: 4311 - adverse event related to procedure: the root cause of this investigation was determined to be procedure related.This is due to the a scan review performed by sme (subject matter expert) which confirmed that this event is likely to be procedure related.4323 - device problem excluded: comprehensive batch review was performed, no issues identified during manufacturing process.Device was manufactured to specification.No causal link between the device and event was identified.The site reported data indicates no device defects before use and no issues during device implant.
Event or Problem Description
Implant date: (b)(6) 2023.Event was reported from extend post market study (b)(4) as arterial clots.Additional information was received on 10th mar 2025: the ae (adverse event) changed from arterial clots to deep vein thrombosis.This report is being submitted as follow up # 1 for manufacturing report 9612515-2025-00015 to provide event closure information for tag0141.

• Brand Name: THORAFLEX HYBRID
• Common Device Name: THORAFLEX HYBRID ANTE-FLO
• 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: 21383080
• Report Number: 9612515-2025-00015
• Device Sequence Number: 15550512
• Product Code: QSK
• UDI-Device Identifier: 05037881027067
• UDI-Public: 05037881027067
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: THA3038X150A
• Device Lot Number: 25172943
• 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: 01/25/2025
• Supplement Date Received by Manufacturer: 01/25/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2022
• 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: Male