MAUDE Adverse Event Report: VASCUTEK LTD THORAFLEX HYBRID PLEXUS

Catalog Number	THP3032X100A-G
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	05/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical trial extend-001 ((b)(6)), on post-operative day 2 ((b)(6) 2023), subject (b)(6) experienced an adverse event of left carotid artery thrombus status post left carotid cutdown.The event was considered recovered, resolved with treatment and resolved without sequelae on (b)(6) 2023.No medication was given to treat the event.Surgical intervention was required -thrombectomy, stent placement and cutdown procedure.Subject continues on the study.
Additional Manufacturer Narrative
Clinical code: 4440- thrombosis/thrombus- left carotid artery thrombus.Impact code: 4624- surgical intervention- thrombectomy, stent placement.4629- device revision or replacement- cutdown procedure.Medical device problem: 3190- insufficient information- additional questions sent to the site.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4111 - communication/interview: additional questions sent to 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 accessible for testing: device remains implanted.Investigation finding: 3233 - results pending completion of investigation.Investigation conclusion: 11 - conclusion not yet available.
Additional Manufacturer Narrative
Clinical code: 4440- thrombosis/thrombus- left carotid artery thrombus.Impact code: 4624- surgical intervention- thrombectomy, stent placement.4629- device revision or replacement- cutdown procedure.Medical device problem: 2993- adverse event without identified device or use problem- the thoraflex hybrid device appears to be performing as intended.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4111 - communication/interview: additional questions sent to the site.3331- analysis of production records: a full batch review was performed for tag00309, and no issues were identified during manufacturing process from raw materials to finished products.4117- device not accessible for testing: device remains implanted.4112- analysis of information provided by user/third party- the event of left common carotid artery (lcca) thrombus was reported to have occurred on (b)(6) 2023, with resolution of the event on the same date.The post-operative ct scan provided was performed on (b)(6) 2023, therefore the lcca thrombus was not present and root cause cannot be established.The thoraflex hybrid device appears to be performing as intended, with exclusion of the dissection primary entry tear and subsequent false lumen thrombosis.4110- trend analysis- a 4 year review was performed for thoraflex hybrid > occlusion/ thrombosis > artery this gave an occurrence rate of less than 0.068%.No trend identified that required action at this time.Investigation finding: 213 - no device problem found- the thoraflex hybrid device appears to be performing as intended, with exclusion of the dissection primary entry tear and subsequent false lumen thrombosis.Investigation conclusion: 67 - no problem detected- no causal link to device deficiency could be confirmed due to limited scans which showed device appears to be performing as intended and no additional information from the site.
Event or Problem Description
Clinical trial extend-001 (b)(4), on post-operative day 2 (on (b)(6) 2023), subject (b)(6) experienced an adverse event of left carotid artery thrombus status post left carotid cutdown.The event was considered recovered, resolved with treatment and resolved without sequelae on 28-may-2023.No medication was given to treat the event.Surgical intervention was required -thrombectomy, stent placement and cutdown procedure.Subject continues on the study.This report is being submitted as final for manufacturing report number: 9612515-2025-00079 to provide event closure information for tag0309.

• 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: 23035527
• Report Number: 9612515-2025-00079
• Device Sequence Number: 9217105
• Product Code: QSK
• UDI-Device Identifier: 05037881026725
• UDI-Public: 05037881026725
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P210006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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 Expiration Date: 04/30/2024
• Device Catalogue Number: THP3032X100A-G
• Device Lot Number: 22326303
• 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: 08/14/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2022
• 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 Sex: Male