MAUDE Adverse Event Report: VASCUTEK LTD THORAFLEX HYBRID; THORAFLEX HYBRID PLEXUS

Model Number	N/A
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Codes	Chest Pain (1776); Clinical Endoleak (4843)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer narrative: clinical code: 4843 - endoleak - endoleak type iii reported.Impact code: 4621 - recognised device or procedural complication- thoraflex hybrid us ifu (301-213-usen) rev 2 lists endoleak as potential adverse event.Device problem code: 4074 - endoleaks - endoleak type iii reported.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: a 4-year review of similar complaints could not be performed as this is the only type iii endoleak reported jan 22 - nov 25.No trend requiring action has been identified.4111 - communication interview: additional information has been requested from the site to aid this investigation.3331 - analysis of production records: full batch review from base fabric to finished product was performed which confirmed the device was manufactured to specification.4117 - device not returned: device remains implanted.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusion: 11 - conclusion not yet available as investigation is ongoing.
Event or Problem Description
Event reported form extend study (nct05639400) as endoleak type 3; the ae description of "endoleak type iii" was added on (b)(6) 2025, with confirmation that the event was associated with a device deficiency.The following additional details were included "persistent false lumen flow with enlargement of the proximal descending thoracic aorta.Apparent type 3 endoleak through the proximal aortic endograft (thoraflex).Patient recently underwent embolization coiling of a potential type iii endoleak.
Additional Manufacturer Narrative
Manufacturer narrative: clinical code: 4843 - endoleak - endoleak type iii reported.1776 - chest pain: site confirmed the patient reported a "funny chest pain" post op day 4 impact code: 4621 - recognised device or procedural complication.- thoraflex hybrid us ifu (301-213-usen) rev 2 lists endoleak as potential adverse event.Device problem code: 4074 - endoleaks - endoleak type iii reported.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: a 4-year review of similar complaints could not be performed as this is the only type iii endoleak reported (b)(6) 2022 - (b)(6) 2025.No trend requiring action has been identified.4111 - communication interview: additional information was received from a call with the site which states the below: ·during the procedure.The clinician usually debranches, takes vascular load stapler with thoraflex hybrid deployed and sewed 1 line of suture to distal cuff, re-perfused then sews another line of suture for hemostasis ·patient reported a "funny chest pain" post op day 4 - ct showed contrast in arterial phase in false lumen.-initial thought was maybe type 2 endoleak but the patient was clinically doing fine -ct scans were consistent possible type 1a endoleak, however the aortogram showed it wasn't a type 1, but the leak was through the thoraflex hybrid.·clinician opinion - the needle may have stabbed through thoraflex hybrid device through during the 2nd layer of suturing which might have caused the endoleak.· patient diagnosed with type 3 endoleak.· plans on performing a planned extension on the patient.3331 - analysis of production records: full batch review from base fabric to finished product was performed which confirmed the device was manufactured to specification.4117 - device not returned: device remains implanted.4112 - analysis of information provided by user/ third party: scan review was performed on (b)(6) 2025 which concluded the below: ·pseudo aneurysm at distal anastomosis on brachiocephalic artery.Endoleak occurring at suture collar of device.·procedure related, no failure in device.Device performing as intended.·the event was determined to be procedure related.Investigation findings: 213 - no device problem found: from the investigation performed which confirmed that, the device was manufactured to specification, there was no issue with the device before or during implant and scan review confirmed the event was related to the procedure and no failure of the device.Device performed as intended.Also, full batch review from base fabric to finished product was performed which confirmed the device was manufactured to specification.Investigation conclusion: 4311 - adverse event related to procedure: from the investigation performed it was confirmed with scan review that the event was related to the procedure.There was no device failure and device performed as intended.Also in the clinician's opinion, the needle may have stabbed through thoraflex hybrid device through during the 2nd layer of suturing which might have caused the endoleak 22 - known inherent risk of device: ifu - (instructions for use) review was performed which stated, thoraflex hybrid us ifu (301-213-usen) rev 2.0 section 6.1 table 2 states endoleak.
Event or Problem Description
Event was reported by extend study - (b)(6).Event reported as endoleak type 3; the site originally recorded the event of endoleak in the study database on (b)(6) 2025.The ae description of "endoleak type iii" was added on (b)(6) 2025, as was the device relationship of "possibly related" and confirmation that the event was associated with a device deficiency.The following additional details were included on the adverse event form "persistent false lumen flow with enlargement of the proximal descending thoracic aorta.3.Apparent type 3 endoleak through the proximal aortic endograft (thoraflex)." please note that the site have yet to complete the device deficiency form in the database.As per provided source notes "patient recently underwent embolization coiling of a potential type iii endoleak." this report is being submitted as follow up #1 for manufacturing report number 9612515-2025-00092 to provide event closure information for tag0343.

• Brand Name: THORAFLEX HYBRID
• Common Device Name: THORAFLEX HYBRID PLEXUS
• 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: 23568968
• Report Number: 9612515-2025-00092
• Device Sequence Number: 10172642
• Product Code: QSK
• UDI-Device Identifier: 05037881026749
• UDI-Public: 05037881026749
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 12/15/2025

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: THP3036X100A
• Device Lot Number: 25777783
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2024
• 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: Female
• Patient Race: Black Or African American