MAUDE Adverse Event Report: VASCUTEK LTD THORAFLEX HYBRID PLEXUS

Catalog Number	THP2830X100A-G
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	02/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On post operative day 4 ((b)(6) 2025), site reported an adverse event (ae) of false lumen thrombosed, with improved expanded true lumen extending from the proximal ascending aorta to the proximal abdominal aorta, at the level of l1 vertebral body.Patient outcome: the thrombosis is ongoing, unresolved with no treatment and is ongoing at time of reporting.The adverse event is considered moderate in severity.The subject continued in the study.Concomitant medications include aspirin, labetalol and nicardipine.
Additional Manufacturer Narrative
Manufacturer narrative: clinical code: 4440 - thrombus/ thrombosis - on post operative day 4 ((b)(6) 2025), site reported an adverse event (ae) of false lumen thrombosis.Impact code: 4648 - insufficient information - the adverse event is ongoing at time of reporting; however, the current patient outcome is to be confirmed.Device problem code: 3190 - insufficient information - an adverse event appears to have occurred but there is not yet enough information available to classify the device problem.Component code: 4755 - part/component/sub-assembly term not applicable type of investigation: 4110 - trend analysis: a 4-year review of similar complaints thoraflex hybrid /occlusion thrombosis events will be performed.4111 - communication interview: additional information has been requested from the site.3331 - analysis of production records: a review of the manufacturing and quality control records for this batch confirmed that the product 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.
Additional Manufacturer Narrative
Manufacturer narrative: clinical code: 4440 - thrombus/ thrombosis - on post operative day 4 ((b)(6) 2025), site reported an adverse event (ae) of false lumen thrombosis.Impact code: 4648 - insufficient information - the adverse event is ongoing at time of reporting; however, the current patient outcome is to be confirmed.Device problem code: 3190 - insufficient information - an adverse event appears to have occurred but there is not yet enough information available to classify the device problem.Component code: 4755 - part/component/sub-assembly term not applicable type of investigation: 4110 - trend analysis: a 4-year review was performed; occurrence rate was less than (b)(4).No trend requiring action at this time.4111 - communication interview: additional information has been requested from the site.3331 - analysis of production records: a review of the manufacturing and quality control records for this batch confirmed that the product was manufactured to specification.4117 - device not returned: device remains implanted investigation findings: 4247-appropriate term/code not available- the complaint has been voided following confirmation from the site that the adverse event was reported to terumo aortic in error.As a result, no investigation or vigilance report is required, and the complaint has been formally closed.Investigation conclusion: 4316 - appropriate term/code not available- the complaint has been voided following confirmation from the site that the adverse event was reported to terumo aortic in error.As a result, no investigation or vigilance report is required, and the complaint has been formally closed.
Event or Problem Description
Extend-001 (nct05639400), patient 015-021, on post operative day 4 (17 feb 25), site reported an adverse event (ae) of false lumen thrombosed, with improved expanded true lumen extending from the proximal ascending aorta to the proximal abdominal aorta, at the level of l1 vertebral body.Patient outcome: the thrombosis is ongoing, unresolved with no treatment and is ongoing at time of reporting.The adverse event is considered moderate in severity.The subject continued in the study.Concomitant medications include aspirin, labetalol and nicardipine.The adverse event has been reported to terumo aortic in error.Investigation will not be applicable and hence no vigilance report will be required.This report is being submitted as follow up #1 for manufacturing report number 9612515-2025-00039 to provide event closure information for tag0220.

• Brand Name: THORAFLEX HYBRID PLEXUS
• Common Device Name: THORAFLEX HYBRID
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan; glasgow, PA49R-R ; UK PA49RR
• MDR Report Key: 21897697
• Report Number: 9612515-2025-00039
• Device Sequence Number: 14311226
• Product Code: QSK
• UDI-Device Identifier: 05037881026718
• UDI-Public: 05037881026718
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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 Catalogue Number: THP2830X100A-G
• Device Lot Number: 25363937
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Race: Black Or African American