MAUDE Adverse Event Report: VASCUTEK LTD THORAFLEC HYBRID ANTEFLO; THORAFLEX HYBRID

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Paresis (1998)
Date of Event	03/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical code: 1998 -paresis: it was reported that the patient had an event left lower extremity weakness on (b)(6) 2025.Health impact: 4625 - additional surgery: the treatment of the event included a lumbar drain which was placed on (b)(6) 2025.Medical device problem: 2993 - adverse event without identified device or use problem: the site confirmed on (b)(6) 2025 that there was no issues with the device before or during implant.4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: no statistical analysis could be performed as this was a 1st time occurrence for this event.4111 - communication/interviews: additional information was received from the site on 10 apr 25 which confirmed the below: there was no issues with the device before or during implant.The ifu was followed, graft was pre-soaked as per ifu.No issue during deployment or with the size of the graft.The patient also got treatment of permissive hypertension.The site believe this event as device related due to the coverage.Also possibly procedure related.There was no indications of thrombus detected in the patient.The indication of the surgery was chronic dissection.The estimated oversize was 5%.There was minimal notable curvature of the patient's anatomy.3331 - analysis of production records: to be performed.4117 - device not accessible for testing: device remains implanted.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusion: 11 - conclusion not yet available.
Event or Problem Description
Following procedure performed on (b)(6) 2025, subject (b)(6) experienced an event of left lower extremity weakness on (b)(6) 2025.Treatment of the event included a lumbar drain which was placed on (b)(6) 2025.The event is ongoing at time of reporting.The subject continues in the study.Concomitant medications include amiodarone, amlodipine, furosemide, esmolol, heparin, aminocaproic acid, nicarpidine, vasopressin, human albumin, aspirin and metropolol.There was no device failure/deficiency reported.
Event or Problem Description
Event was reported by clinical study - extend - (b)(6).Following procedure performed on (b)(6) 2025, subject (b)(6) experienced an event of left lower extremity weakness on (b)(6) 2025.Treatment of the event included a lumbar drain which was placed on (b)(6) 2025.The event is ongoing at time of reporting.The subject continues in the study.Concomitant medications include amiodarone, amlodipine, furosemide, esmolol, heparin, aminocaproic acid, nicarpidine, vasopressin, human albumin, aspirin and metropolol.There was no device failure/deficiency reported.This report is being submitted as follow up 1 for manufacturing report number 9612515-2025-00038 to provide event closure information for (b)(4).
Additional Manufacturer Narrative
Clinical code: 1998 -paresis: it was reported that the patient had an event left lower extremity weakness on (b)(6) 2025.Health impact: 4625 - additional surgery: the treatment of the event included a lumbar drain which was placed on (b)(6) 2025.Medical device problem: 2993 - adverse event without identified device or use problem: the site confirmed on (b)(6) 2025 that there was no issues with the device before or during implant.4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: no statistical analysis could be performed as this was a 1st time occurrence for this event.4111 - communication/interviews: additional information was received from the site on 10 apr 2025 which confirmed the below: there was no issues with the device before or during implant.The ifu was followed, graft was pre-soaked as per ifu.No issue during deployment or with the size of the graft.The patient also got treatment of permissive hypertension.The site believe this event as device related due to the coverage.Also possibly procedure related.There was no indications of thrombus detected in the patient.The indication of the surgery was chronic dissection.The estimated oversize was 5%.There was minimal notable curvature of the patient's anatomy.3331 - analysis of production records: comprehensive batch review had been performed, no issue were identified during manufacture of this device.Device manufactured to specification.4117 - device not accessible for testing: device remains implanted.4112 - analysis of information provided by user/third party: scan review was performed which concluded the below: the stented section of the thoraflex hybrid device has an excessive oversize; 40mm stent deployed in 24.6mm true lumen.The graft section and attached branch are fully patent.There is no suggestion of a device deficiency in the imaging provided.The scan review had the device relationship as undetermined.Investigation findings: 213 - no device problem found: comprehensive batch review had been performed, no issue were identified during manufacture of this device.Device manufactured to specification.Also site confirmed, there was no issues with the device before or during implant.Investigation conclusion: 4315 - cause not established: with the investigation performed we were not able to establish a root cause for this event.The root cause of this event was determined to be no causal link to device deficiency as during scan review it was confirmed that, the graft section and attached branch are fully patent.There is no suggestion of a device deficiency in the imaging provided.

• Brand Name: THORAFLEC HYBRID ANTEFLO
• 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: laura allan ; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 21917302
• Report Number: 9612515-2025-00038
• Device Sequence Number: 8714895
• Product Code: QSK
• UDI-Device Identifier: 05037881027081
• UDI-Public: 05037881027081
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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 Model Number: N/A
• Device Catalogue Number: THA3240X150A
• Device Lot Number: 25355103
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2023
• 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; Other
• Patient Age: 59 YR
• Patient Sex: Male