MAUDE Adverse Event Report: VASCUTEK LTD THORAFLEX HYBRID GEN 2 ANTE FLO

Model Number	UNKNOWN
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the extend-001 study: implant date was (b)(6)2024, event date was 16 may 24.Event reported as endoleak through the existing thoracic endovascular aortic devices.Thoracic endovascular aortic aneurysm repair not involving lt subclavian artery relines the existing devices and extend to treat the poor true lumen expansion in the distal descending thoracic aorta.Surgical intervention was marked as required, but no confirmation of what intervention was performed.Patient pre-existing conditions: hypertension, type 2 diabetes, erectile dysfunction, and previous emergent type a dissection repair ascending aorta replacement.This event occurred after procedure and the period of the event occurred for 36 days.This event has been marked as device related (without device deficiency description), possibly procedure related and no information if is related to patient preexisting condition.Patient recovered and resolved with treatment on (b)(6) 2024.
Additional Manufacturer Narrative
Manufactures narrative clinical code 4580 - insufficient information: a/w further information from the site impact code 4624 - surgical intervention: surgical intervention was marked as required, but no confirmation of what intervention was performed.Medical device problem 4074 - endoleaks: event reported as endoleak through the existing thoracic endovascular aortic devices.Component code 4755 - part/component/sub-assembly term not applicable type of investigation 4110 - trend analysis: a 5 year review of similar complaints (leakage > endoleak) gave an occurrence rate of 0.100% (complaints v sales).No negative trend in the number of complaints received has been identified.4111 - communication/investigation: a/w further information from the site 3331 - analysis of production records: a review of manufacturing and qc records confirmed that there were no issues with the manufacture of the device.4117 - device not accessible for testing: device remains implanted investigation findings 3233 - results pending completion of investigation investigation conclusion 11 - conclusion not yet available.
Additional Manufacturer Narrative
Manufactures narrative: clinical code 4581 - appropriate clinical signs, symptoms, conditions term / code not available: information received from this site does not provide any clinical issues with the patient.The patient recovered and event was resolved with treatment on the (b)(6) 2024.Patient was discharged on the (b)(6) 2024.Impact code 4624 - surgical intervention: surgical intervention was marked as required, thoracic endovascular aortic aneurysm repair not involving left subclavian artery relines the existing devices and extend to treat the poor true lumen expansion in the distal descending thoracic aorta.Medical device problem 4074 - endoleaks: event reported as endoleak through the existing thoracic endovascular aortic devices.Component code 4755 - part/component/sub-assembly term not applicable.Type of investigation 4110 - trend analysis: (b)(4).4111 - communication/investigation: further information was received from the site on 26 jun 24; this confirmed that this event was not device related or procedure related.3331 - analysis of production records: comprehensive batch review was performed for (b)(6), this did not identify any issues during the manufacturing process.4117 - device not accessible for testing: device remains implanted.Investigation findings 213 - no device problem found: further information was received from the site on 26 jun 24; this confirmed that this event was not device related or procedure related.Investigation conclusion: 22 - known inherent risk of device: thoraflex hybrid us ifu (301-213-usen)rev 2.0 review was performed and in section 6.1 endoleak is mentioned as a potential adverse event.4310 - cause cannot be traced to device: further information was received from the site on 26 jun 24; this confirmed that this event was not device related or procedure related.
Event or Problem Description
As reported by the (b)(4) study: implant date was (b)(6) 2024, event date was (b)(6) 2024.Event reported as endoleak through the existing thoracic endovascular aortic devices.Thoracic endovascular aortic aneurysm repair not involving lt subclavian artery relines the existing devices and extend to treat the poor true lumen expansion in the distal descending thoracic aorta.Surgical intervention was marked as required, but no confirmation of what intervention was performed.Patient pre-existing conditions: hypertension, type 2 diabetes, erectile dysfunction, and previous emergent type a dissection repair ascending aorta replacement.This event occurred after procedure and the period of the event occurred for 36 days.This event has been marked as device related (without device deficiency description), possibly procedure related and no information if is related to patient preexisting condition.Patient recovered and resolved with treatment on (b)(6) 2024.This report is being submitted as a follow up 1 for manufacturing report #9612515-2024-00043 to provide event closure information for (b)(4).

• Brand Name: THORAFLEX HYBRID GEN 2 ANTE FLO
• 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: jason whittle ; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA4 (-RR ; UK PA4 (RR
• MDR Report Key: 19556172
• Report Number: 9612515-2024-00043
• Device Sequence Number: 17821575
• Product Code: QSK
• UDI-Device Identifier: 05037881026848
• UDI-Public: 05037881026848
• 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: 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): 06/28/2024

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: Lay User/Patient
• Device Expiration Date: 08/31/2024
• Device Model Number: UNKNOWN
• Device Catalogue Number: THA3036150A
• Device Lot Number: 25039012
• 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: 05/23/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2022
• 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: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male