MAUDE Adverse Event Report: VASCUTEK LTD THORAFLEX HYBRID; THORAFLEX HYBRID PLEXUS

Model Number	N/A
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Device Endoleak (4074)
Health Effect - Clinical Codes	Stroke/CVA (1770); Thrombosis/Thrombus (4440)
Date of Event	08/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical code: 4440- thrombosis/thrombus: reported withing event intake form as thrombus was found at the branch right of the innominate artey.1770 - stroke/cva: event was reported as stroke with intake form.Impact code: 4624 - surgical intervention: patient was treated with mechanical thrombectomy on (b)(6) 2024 4642- additional device required: relay pro nbc ( cat no: 28-n4-46-209-46u , serial no: (b)(6) ) was implanted on (b)(6) 2024.Medical device problem: 4074- endoleak: · on (b)(6) 2024, for a type 1a endoleak patient underwent an unplanned mesenteric angiogram with relining of renal and coeliac stents with vascular surgery.Endoleak resolved following procedure.An endovascular procedure (including percutaneous transluminal angioplasty, atherectomy, stenting) without thrombectomy or thrombolysis was performed, and an atrium medical device was inserted in the left and right renal arteries and coeliac artery.The intervention was not required as a result of a device deficiency.· on (b)(6) 2024, for a type 2 endoleak the patient underwent a planned left carotid subclavian bypass using an 8mm dacron graft and left subclavian artery embolization.Intervention was classed as minor.An atrium medical device was used in the left carotid.The intervention was not required as a result of a device deficiency.· scan review confirmed that there appears to be a type iiia endoleak at the overlap of the two relay devices, which should be relined to exclude the endoleak.2889- deformation due to compressive stress: scan review confirmed that despite the excessive oversize of the thoraflex hybrid device, it appears that all devices are performing as intended, with no clear cause of the thrombus formation identified.The event occurred approximately 6 weeks after the last available imaging.The posterior orientation of the bct branch and resultant kinking of the branch may have contributed to the thrombus formation.Component code: 4755- part/component/ sub-assembly term not applicable.Type of investigation: 4110- trend analysis: 4 year review was performed that gave an occurrence rate of 0.094%.Trend was identified that required action.4111- communication/ interview: additional info was received on 07 jan 25 which confirmed the below: · the patient has a embolic middle cerebral artery stroke.· ther event occurred 220 days after the initial procedure and 177 days after the extension procedure.· patient outcome is "recovered", and type of recovery is "resolved without sequalae".· the patient had a pre-existing device implanted into their vascular system; saint jude mechanical bileaflet aortic valve to repair extensive type a aortic dissection with extensive haematoma (29mm sinotubular junction aortic valve replacement).· distal seal was not intended or obtained due to planned evar extension.· there was a total of 43 day between the thoraflex hybrid implantation and the relay implantation.3331- analysis of product records: comprehensive batch review was performed, no issues identified during manufacturing process.Device was manufactured to specification.4112- analysis of information provided by user/ third party: scan review was performed on (b)(6) 2024 which gave conclusion below: · a thoraflex hybrid plexus device was initially implanted, with an extremely high oversize of the stented section through the narrow true lumen of the descending aorta.Of the three branches provided on the device, only two were used to reimplant the bct and lcca, which both have residual dissection distal to the branch anastomosis.Relining of the thoraflex hybrid device with two relay nbs devices has promoted a degree of expansion of the stent rings of the device however they have not fully expanded.Distal to the thoraflex hybrid device, the stents of the relay devices have expanded well, with the exception of the most distal ring.There appears to be a type iiia endoleak at the overlap of the two relay devices, which should be relined to exclude the endoleak.There is no thrombus formation demonstrated within the devices or branches.· despite the excessive oversize of the thoraflex hybrid device, it appears that all devices are performing as intended, with no clear cause of the thrombus formation identified.The event occurred approximately 6 weeks after the last available imaging.The posterior orientation of the bct branch and resultant kinking of the branch may have contributed to the thrombus formation.4117- device not accessible for testing: device remains implanted.Investigation findings: 3233- result pending completion of investigation: investigation conclusion: 11- conclusion not yet available.
Event or Problem Description
The patient was admitted to outside hospital on (b)(6) 2024 with left sided hemiplegia and sensory change.Patient was treated with mechanical thrombectomy on (b)(6) 2024 and was found to have thrombus at the branch of right innominate artery.Investigator assessment of possibly related to device, undetermined if related to thoraflex hybrid or relaypro nbs specifically.The patient outcome was resolved on (b)(6) 2024.
Event or Problem Description
The patient was admitted to outside hospital on (b)(6)2024 with left sided hemiplegia and sensory change.Patient was treated with mechanical thrombectomy on (b)(6)2024 and was found to have thrombus at the branch of right innominate artery.Investigator assessment of possibly related to device, undetermined if related to thoraflex hybrid or relaypro nbs specifically.The patient outcome was resolved on (b)(6)2024.This report is being submitted as follow up #1 for manufacturing report number 9612515-2025-00009 to provide event closure information for tag0134.
Additional Manufacturer Narrative
Clinical code: 4440- thrombosis/thrombus: reported withing event intake form as thrombus was found at the branch right of the innominate artey.1770 - stroke/cva: event was reported as stroke with intake form.Impact code: 4624 - surgical intervention: patient was treated with mechanical thrombectomy on (b)(6) 2024.4642- additional device required: relay pro nbc (cat no: 28-n4-46-209-46u, serial no: (b)(6)) was implanted on (b)(6) 2024.Medical device problem: 4074- endoleak: · on (b)(6)2024, for a type 1a endoleak patient underwent an unplanned mesenteric angiogram with relining of renal and coeliac stents with vascular surgery.Endoleak resolved following procedure.An endovascular procedure (including percutaneous transluminal angioplasty, atherectomy, stenting) without thrombectomy or thrombolysis was performed, and an atrium medical device was inserted in the left and right renal arteries and coeliac artery.The intervention was not required as a result of a device deficiency.· on (b)(6)2024, for a type 2 endoleak the patient underwent a planned left carotid subclavian bypass using an 8mm dacron graft and left subclavian artery embolization.Intervention was classed as minor.An atrium medical device was used in the left carotid.The intervention was not required as a result of a device deficiency.· scan review confirmed that there appears to be a type iiia endoleak at the overlap of the two relay devices, which should be relined to exclude the endoleak.2889- deformation due to compressive stress: scan review confirmed that despite the excessive oversize of the thoraflex hybrid device, it appears that all devices are performing as intended, with no clear cause of the thrombus formation identified.The event occurred approximately 6 weeks after the last available imaging.The posterior orientation of the bct branch and resultant kinking of the branch may have contributed to the thrombus formation.Component code: 4755- part/component/ sub-assembly term not applicable.Type of investigation: 4110- trend analysis: 4 year review was performed that gave an occurrence rate of 0.094%.Trend was identified that required action.4111- communication/ interview: additional info was received on 07 jan 2025 which confirmed the below: · the patient has a embolic middle cerebral artery stroke.· ther event occurred 220 days after the initial procedure and 177 days after the extension procedure.· patient outcome is "recovered", and type of recovery is "resolved without sequalae".· the patient had a pre-existing device implanted into their vascular system; saint jude mechanical bileaflet aortic valve to repair extensive type a aortic dissection with extensive haematoma (29mm sinotubular junction aortic valve replacement).· distal seal was not intended or obtained due to planned evar extension.· there was a total of 43 day between the thoraflex hybrid implantation and the relay implantation.3331- analysis of product records: comprehensive batch review was performed, no issues identified during manufacturing process.Device was manufactured to specification.4112- analysis of information provided by user/ third party: scan review was performed on (b)(6)2024 which gave conclusion below · a thoraflex hybrid plexus device was initially implanted, with an extremely high oversize of the stented section through the narrow true lumen of the descending aorta.Of the three branches provided on the device, only two were used to reimplant the bct and lcca, which both have residual dissection distal to the branch anastomosis.Relining of the thoraflex hybrid device with two relay nbs devices has promoted a degree of expansion of the stent rings of the device however they have not fully expanded.Distal to the thoraflex hybrid device, the stents of the relay devices have expanded well, with the exception of the most distal ring.There appears to be a type iiia endoleak at the overlap of the two relay devices, which should be relined to exclude the endoleak.There is no thrombus formation demonstrated within the devices or branches.· despite the excessive oversize of the thoraflex hybrid device, it appears that all devices are performing as intended, with no clear cause of the thrombus formation identified.The event occurred approximately 6 weeks after the last available imaging.The posterior orientation of the bct branch and resultant kinking of the branch may have contributed to the thrombus formation.4117- device not accessible for testing: device remains implanted.Investigation findings: 213 - no device problem found: comprehensive batch review was performed, no issues identified during manufacturing process.Device was manufactured to specification.Investigation conclusion: 67 - no problem detected: comprehensive batch review was performed, no issues identified during manufacturing process.Device was manufactured to specification.

• Brand Name: THORAFLEX HYBRID
• Common Device Name: THORAFLEX HYBRID PLEXUS
• 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: 21263125
• Report Number: 9612515-2025-00009
• Device Sequence Number: 17211773
• Product Code: QSK
• UDI-Device Identifier: 05037881026725
• UDI-Public: 05037881026725
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P210006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: THA3032X100A
• Device Lot Number: 25382125
• 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: 01/04/2025
• Supplement Date Received by Manufacturer: 01/04/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2023
• 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
• Patient Sex: Male