MAUDE Adverse Event Report: VASCUTEK LTD THORAFLEX HYBRID PLEXUS

Model Number	N/A
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	02/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical code 4440 - thrombosis/thrombus : the event was reported as, the patient experienced a serious adverse event (sae)of femoral artery thrombus.Impact code 4625 - additional surgery : site reported a thrombectomy and repair of the femoral artery was performed.Medical device code 2423 - obstruction of flow : the event was reported as, the patient experienced a serious adverse event (sae)of femoral artery thrombus.Component code 4755 - part/component/ sub-assembly term not applicable type of investigation 4110 - trend analysis: 4-year review was performed, occurrence rate was 0.054%.No trend was identified requiring action at this time.4111 - communication/ interviews: additional information was provided by the site on (b)(6) 2025 which confirmed the below: · the patient missed one year follow up sand will be rescheduled · the patient has a mechanical heart valve and was on anticoagulant therapy (warfarin) as of the date medical history was performed, which was nine days prior to the index procedure.He also received heparin intraoperatively and at least one dose of lovenox.· there was no thrombus generation detected from scans or blood tests.The operation note states ' flow in left leg beyond femoral artery cannulation site, but signal was weak, and given underlying connective tissue disorder and the need to use femoral cannulation, it was thought best to consult vascular surgery'.Therefore, thrombus discovered and treated during operation.· no extension device was used and none is planned.Scan review was not performed for this case as the sme confirmed the below: · it is clear that the event occurred as a result of femoral artery cannulation - which is not the insertion site of the thoraflex hybrid device.While this event may be procedure related, it is certainly not device related.The issue was resolved on the implant date, so review of the post op imaging would not be worthwhile.4117 - device not accessible for testing: device remains implanted.Investigation findings 3233 - results pending completion of investigation.Investigation conclusions 11 - conclusion not yet available.
Event or Problem Description
On post operative day 0 (b)(6) 2024), the patient experienced a serious adverse event (sae)of femoral artery thrombus, further commentary states the flow of the left leg beyond the femoral artery cannulation site had a weak signal'.Treatment of the event included vascular surgery - a thrombectomy and repair of the femoral artery was performed.The event was considered resolved on post-op day 0 and the patient continued in the study.Concomitant medications (taken at the time of the event) included aspirin 81mg, warfarin 1mg, enoxaparin sodium and heparin.
Event or Problem Description
Event was reported from clinical study extend - (b)(4).On post operative day 0 ((b)(6) 2024), the patient experienced a serious adverse event (sae)of femoral artery thrombus, further commentary states the flow of the left leg beyond the femoral artery cannulation site had a weak signal'.Treatment of the event included vascular surgery - a thrombectomy and repair of the femoral artery was performed.The event was considered resolved on post-op day 0 and the patient continued in the study.Concomitant medications (taken at the time of the event) included aspirin 81mg, warfarin 1mg, enoxaparin sodium and heparin.This report is being submitted as follow up #1 for manufacturing report number 9612515-2025-00029 to provide event closure information for (b)(4).
Additional Manufacturer Narrative
Clinical code: 4440 - thrombosis/thrombus: the event was reported as; the patient experienced a serious adverse event (sae) of femoral artery thrombus.Impact code: 4625 - additional surgery: site reported a thrombectomy and repair of the femoral artery was performed.4644 - medication required: site reported, concomitant medications (taken at the time of the event) included aspirin 81mg, warfarin 1mg, enoxaparin sodium and heparin.Medical device code: 2423 - obstruction of flow: the event was reported as; the patient experienced a serious adverse event (sae) of femoral artery thrombus.Component code: 4755 - part/component/ sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: 4-year review was performed; occurrence rate was (b)(4).No trend was identified requiring action at this time.4111 - communication/ interviews: additional information was provided by the site on (b)(6) 2025 which confirmed the below: · the patient missed one year follow up sand will be rescheduled · the patient has a mechanical heart valve and was on anticoagulant therapy (warfarin) as of the date medical history was performed, which was nine days prior to the index procedure.He also received heparin intraoperatively and at least one dose of lovenox.· there was no thrombus generation detected from scans or blood tests.The operation note states ' flow in left leg beyond femoral artery cannulation site, but signal was weak, and given underlying connective tissue disorder and the need to use femoral cannulation, it was thought best to consult vascular surgery'.Therefore, thrombus discovered and treated during operation.· no extension device was used and none is planned.Scan review was not performed for this case as the sme confirmed the below: · it is clear that the event occurred as a result of femoral artery cannulation - which is not the insertion site of the thoraflex hybrid device.While this event may be procedure related, it is certainly not device related.The issue was resolved on the implant date, so review of the post op imaging would not be worthwhile.4117 - device not accessible for testing: device remains implanted.3331 - analysis of production records: comprehensive batch review had been performed, no issue were identified during manufacture of this device.Device manufactured to specification.Investigation findings: 213 - no device problem found: see below information · the site confirmed no issue with the device before or during implant.· comprehensive batch review had been performed, no issue were identified during manufacture of this device.Device manufactured to specification.· scan review was not performed for this case as the sme confirmed the below: it is clear that the event occurred as a result of femoral artery cannulation - which is not the insertion site of the thoraflex hybrid device.While this event may be procedure related, it is certainly not device related.The issue was resolved on the implant date.Investigation conclusions: 4310 - cause traced to non-device related factors: the root cause of this event was determined to be not device related.See below information: see below information · the site confirmed no issue with the device before or during implant.· comprehensive batch review had been performed, no issue were identified during manufacture of this device.Device manufactured to specification.· scan review was not performed for this case as the sme confirmed the below: it is clear that the event occurred as a result of femoral artery cannulation - which is not the insertion site of the thoraflex hybrid device.While this event may be procedure related, it is certainly not device related.The issue was resolved on the implant date.

• Brand Name: THORAFLEX HYBRID PLEXUS
• 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: 21686992
• Report Number: 9612515-2025-00029
• Device Sequence Number: 8668156
• Product Code: QSK
• UDI-Device Identifier: 05037881026749
• UDI-Public: 05037881026749
• Combination Product (Y/N): N
• 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): 04/30/2025

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
• Device Model Number: N/A
• Device Catalogue Number: THP3036X100A
• Device Lot Number: 25344898
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2023
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Race: White