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) jan2022- jun2026, this gave an occurrence rate of (b)(4).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.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: 25887482
• Report Number: 9612515-2026-00046
• Device Sequence Number: 9790252
• Product Code: QSK
• UDI-Device Identifier: 05037881173283
• UDI-Public: 05037881173283
• 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: THP2224X100E
• Device Lot Number: 26518651
• 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: 04/06/2026
• 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