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	Clinical Endoleak (4843)
Date of Event	01/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer narrative: clinical code: e.4843 -endoleak- worsening of type 1b endoleak reported from extend study.Impact code: f.4624- surgical intervention - treatment of the event on (b)(6) 2026 included extension thoracic endovascular aortic repair (tevar) via right cfa (understood to be common femoral artery) cutdown.The vascular procedure included percutaneous access of the right femoral artery with a 7-french sheath, a right iliac angiogram, and a stenting of the right common iliac artery and external iliac.Device problem code: a.3190 -insufficient information.- worsening type 1b endoleak reported, site documented in electronic data capture (edc) system that there was no device deficiency during or after the index or extension procedure and no endoleaks present at the end of either procedure.Component code: g.4755 - part/component/sub-assembly term not applicable.Type of investigation: b.4110 - trend analysis: -thoraflex hybrid sales (b)(6)2022 - (b)(6) 2025 vs endoleak type 1b events (b)(6) 2022 - (b)(6) 2026 had an occurrence rate of (b)(4) no trend requiring action has been identified.4111 - communication interview: additional information ( scans) have been requested to aid this investigation.3331 - analysis of production records: full batch review will be performed from base fabric to finished product for device id- 25206109.4117 - device not returned: device remains implanted.Investigation findings: c.3233 - results pending completion of investigation.Investigation conclusion: d.11 - conclusion not yet available as investigation is ongoing.
Event or Problem Description
Event of worsening type 1b endoleak reported form extend study (b)(6).On post operative day 722(index procedure)/284(extension procedure), the subject had a (computerised tomography) ct scan on (b)(6) 2026 which showed multiple stable unclassified endoleaks in the proximal stent and midportion of the stent with overall stable aggregate diameter measuring up to 7.2cm.(b)(6) 2025, cta (computed tomography angiography) revealed interval growth of the proximal descending aorta measuring a maximum of 7.1 cm in diameter.Follow-up imaging in (b)(6) 2025 showed ongoing leak from the distal graft.Treatment of the event on (b)(6) 2026 included extension thoracic endovascular aortic repair (tevar) via right cfa (understood to be common femoral artery) cutdown.The vascular procedure included percutaneous access of the right femoral artery with a 7-french sheath, a right iliac angiogram, and a stenting of the right common iliac artery and external iliac.Type 1b endoleak of a thoracic endovascular aortic repair graft done previously after the patient has an extensive history of type a aortic dissection and extensive reconstruction.This intervention was not required as a result of a device deficiency.A new terumo relaypro nbs device was implanted (cat no: 28-n4-44-164-44u).As this event or worsening type 1b endoleak has been reported with no device deficiency and no indication of which of the multiple devices implanted the endoleak relates to additional information has been requested form the site to clarify device relationship.).
Event or Problem Description
Event of worsening type 1b endoleak reported form extend study (b)(4).On post operative day 722(index procedure)/284(extension procedure), the subject had a (computerised tomography) ct scan on (b)(6) 2026 which showed multiple stable unclassified endoleaks in the proximal stent and midportion of the stent with overall stable aggregate diameter measuring up to 7.2cm.On (b)(6) 2025, cta (computed tomography angiography) revealed interval growth of the proximal descending aorta measuring a maximum of 7.1 cm in diameter.Follow-up imaging in (b)(6) 2025 showed ongoing leak from the distal graft.Treatment of the event on (b)(6)2026 included extension thoracic endovascular aortic repair (tevar) via right cfa (understood to be common femoral artery) cutdown.The vascular procedure included percutaneous access of the right femoral artery with a 7-french sheath, a right iliac angiogram, and a stenting of the right common iliac artery and external iliac.Type 1b endoleak of a thoracic endovascular aortic repair graft done previously after the patient has an extensive history of type a aortic dissection and extensive reconstruction.This intervention was not required as a result of a device deficiency.A new terumo relaypro nbs device was implanted (cat no: 28-n4-44-164-44u).As this event or worsening type 1b endoleak has been reported with no device deficiency and no indication of which of the multiple devices implanted the endoleak relates to additional information has been requested form the site to clarify device relationship.This report is being submitted as follow up #1 for manufacturing report number 9612515-2026-00006 to provide event closure information for (b)(4).
Additional Manufacturer Narrative
Manufacturer narrative: clinical code: e 4843 -endoleak- worsening of type 1b endoleak reported from extend study.Impact code: f 4624- surgical intervention - treatment of the event on (b)(6) 2026 included extension thoracic endovascular aortic repair (tevar) via right cfa(understood to be common femoral artery) cutdown.The vascular procedure included percutaneous access of the right femoral artery with a 7-french sheath, a right iliac angiogram, and a stenting of the right common iliac artery and external iliac.Device problem code :a 2993 -iadverse event without device or use problem.- worsening type 1b endoleak reported, site documented in electronic data capture (edc) system that there was no device deficiency during or after the index or extension procedure and no endoleaks present at the end of either procedure.Component code: g 4755 - part/component/sub-assembly term not applicable.Type of investigation: b 4110 - trend analysis: -thoraflex hybrid sales (b)(6) vs endoleak type 1b events jan 22 - jan 26 had an occurrence rate of (b)(4) no trend requiring action has been identified.4111 - communication interview: additional information (scans) have been requested to aid this investigation.3331 - analysis of production records: full batch review will be performed from base fabric to finished product for device id- 25206109 which confirmed the device was manufactured to specification.4117 - device not returned: device remains implanted.4112 - analysis of information provided by a third party - office notes were reviewed which stated " (b)(6) 2017 tevar (thoracic endovascular repair) was performed using a (36 x 200mm valiant) with 2 gore tag 37mm stents up to the level of the carotid artery due to type 1 endoleak.Investigation findings: c 213 - no device problem found, full batch review was performed form base fabric to finished product for device id- 25206109 which confirmed the device was manufactured to specification.Investigation conclusion: d 40 - cause traced to another device - additional information on the event was reviewed and stated on 28 apr 2017 a tevar (thoracic endovascular repair) was performed using a (36 x 200mm valiant) with 2 gore tag 37mm stents up to the level of the carotid artery due to type 1 endoleak.As the thoraflex hybrid device was implanted on (b)(6) 2024 and an extension procedure was performed on (b)(6) 2025 for which the site documented in electronic data capture (edc) system that there was no device deficiency during or after the index or extension procedure and no endoleaks present at the end of either procedure.The worsening of the type 1 endoleak is not considered related to the thoraflex hybrid device.

• Brand Name: THORAFLEX HYBRID
• Common Device Name: THORAFLEX HYBRID ANTE-FLO
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 24452309
• Report Number: 9612515-2026-00006
• Device Sequence Number: 10051754
• Product Code: QSK
• UDI-Device Identifier: 05037881027050
• UDI-Public: 05037881027050
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: THA3036X150A
• Device Lot Number: 25206109
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2023
• 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