MAUDE Adverse Event Report: Vascutek LTD Thoraflex Hybrid Plexus

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical code: 4440 - thrombosis/thrombus: the site reported the event as a thrombus.Impact code: 4648 - insufficient health impact information: awaiting further information.Medical device problem code: 3190 - insufficient device problem information: awaiting further information.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: four year review was performed for thoraflex hybrid > occlusion/thrombosis > all failure categories (excluding emboli/stenosis) jan22- jun26, this gave an occurrence rate of 0.206%.Increasing trend was identified and meeting was arranged with sme's(subject matter experts) to review this trend and discuss next steps at this time.3331 - analysis of production records: comprehensive batch review was performed, no issues were identified and the device was manufactured to required specification.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusion: 11 - conclusion not yet available.
Event or Problem Description
Events reported from insel gruppe ag - 3064, via swissmedic report.Events reported as thrombus after frozen elephant trunk.Thrombus at the distal stent end of the frozen elephant trunk is a well-known complication.In the literature, the incidence is given as about 8-16%.Recently, we have had the impression that this complication is occurring more often in our country.The site compiled the cases of the last three months, it was found that 5 out of 12 patients had a distal thrombus, which is significantly higher than the rate described in the literature.This is significantly higher than the rate described in the literature.In addition, there was a case with serious clinical consequences last november.Despite careful intra-operative measures and established avoidance strategies on our part, thrombi formation continues to occur, which is why we would like to report this.

• Brand Name: Thoraflex Hybrid Plexus
• Common Device Name: Thoraflex Hybrid
• Manufacturer (Section D): Vascutek LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA49R R; UK PA49RR
• Manufacturer (Section G): Vascutek LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA49R R; UK PA49RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA49R-R ; UK PA49RR
• MDR Report Key: 25887429
• Report Number: 9612515-2026-00042
• Device Sequence Number: 10099440
• Product Code: QSK
• UDI-Device Identifier: 05037881031750
• UDI-Public: 05037881031750
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P210006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: THP3032X100B-G
• Device Lot Number: 25909927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2026
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 07/21/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2024
• 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
• Patient Sex: Unknown