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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	07/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical trial: extend-001 (b)(4).Thoraflex hybrid was implanted on (b)(6) 2023.No distal seal was intended due to a planned evar (understood to be endovascular aortic repair) extension and no distal seal was obtained.No endoleak was present at the end of the procedure.Delivery of the thoraflex hybrid was successful, deployed in planned location and withdrawal of delivery system was successful.No device deficiencies occurred during the index th (understood to be thoraflex hybrid) procedure.Event details - rupture (onset date 17-jul-24, resolved on (b)(6) 2024).Contained rupture of the descending thoracic aorta distal to previous endovascular aortic repair.The clinician/site have reported this event as not related to procedure and not related to device.During their regular review of extend adverse events, the study medical monitor has reviewed and marked this event as possibly related to the device.Surgical procedure carried out - tevar on (b)(6) 2024.Terumo catalogue number 2312050409.Outcome of event has been recorded as resolved with treatment.
Additional Manufacturer Narrative
Clinical code (e) 2208- rupture- contained rupture of the descending thoracic aorta distal to previous endovascular aortic repair.Impact code (f) 4624- surgical intervention- a tevar (thoracic endovascular aortic repair) was performed on (b)(6) 24.Terumo catalogue number 2312050409.Outcome of event has been recorded as resolved with treatment.Medical device problem code (a) 2993- adverse event without identified device or use problem.Component code (g) 4755- part/component/sub-assembly term not applicable.Type of investigation (b) 4111- communication / interviews- awaiting information from complainant.4111- device not accessible for testing- device remains implanted.4110- trend analysis- a review of similar events (thoraflex hybrid rupture events jan 2024 - aug2024vs thoraflex hybrid sales on jan 2020 - jul 2024) gave an occurrence rate of (b)(4) (complaints vs sales).No trend was identified requiring action at this time.Investigation findings (c) 3233- results pending completion of investigation.Investigation conclusions (d) 11- conclusion not yet available.
Event or Problem Description
Clinical trial: extend-001 (b)(6).Thoraflex hybrid was implanted on (b)(6) 2023.No distal seal was intended due to a planned evar (understood to be endovascular aortic repair) extension and no distal seal was obtained.No endoleak was present at the end of the procedure.Delivery of the thoraflex hybrid was successful, deployed in planned location and withdrawal of delivery system was successful.No device deficiencies occurred during the index th (understood to be thoraflex hybrid) procedure.Event details - rupture (onset date (b)(6) 2024, resolved (b)(6) 2024).Contained rupture of the descending thoracic aorta distal to previous endovascular aortic repair.The clinician/site have reported this event as not related to procedure and not related to device.During their regular review of extend adverse events, the study medical monitor has reviewed and marked this event as possibly related to the device.Surgical procedure carried out - tevar (b)(6) 2024.Terumo catalogue number 2312050409.Outcome of event has been recorded as resolved with treatment.Follow up #1: this event is being submitted as a follow up #1 for mfg report number 9612515-2024-00057 to provide event closure information for (b)(4).
Additional Manufacturer Narrative
Clinical code (e): 2208- rupture- contained rupture of the descending thoracic aorta distal to previous endovascular aortic repair.Impact code (f): 4624- surgical intervention- a tevar (thoracic endovascular aortic repair) was performed on (b)(6) 2024.Terumo catalogue number 2312050409.Outcome of event has been recorded as resolved with treatment.Medical device problem code (a): 2993- adverse event without identified device or use problem.Component code (g): 4755- part/component/sub-assembly term not applicable.Type of investigation (b): 4111- communication / interviews- information received from the complainant confirmed that no endoleaks occurred which could have correlated to the event, and no infection, fever, or inflammation have been reported.4117- device not accessible for testing- device remains implanted.3331- analysis of product records- a full batch review was performed from raw material to finished product.No issues were found with the manufacture of the device.4110- trend analysis- a review of similar events (thoraflex hybrid rupture events jan 2024 - aug 2024 vs thoraflex hybrid sales jan 2020 - jul 2024) gave an occurrence rate of (b)(4) (complaints vs sales).No trend was identified requiring action at this time.4112- analysis of data provided by user/third party- a review of patient scans provided by the complainant, demonstrating a distal stent induced new entry tear at the level of the distal stent ring.This is likely a result of the high oversizing of the device caused by the narrowing of the aortic true lumen.No endoleak was present and no aneurysm growth detected.Investigation findings (c): 213- no device problem found- the reported stent induced new distal tear is likely a result of the high oversizing of the device, which itself is due to a narrowing of the aortic true lumen.This root cause of this event has been determined to be patient related with no device problem found.Investigation conclusions (d): 50- adverse event related to patient condition- the reported stent induced new distal tear is likely a result of the high oversizing of the device, which itself is due to a narrowing of the aortic true lumen.This root cause of this event has been determined to be patient related with no device problem found.

• Brand Name: THORAFLEX HYBRID
• Common Device Name: THORAFLEX HYBRID ANTEFLO
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, glasgow PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan business 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: 20083291
• Report Number: 9612515-2024-00057
• Device Sequence Number: 7562123
• Product Code: QSK
• UDI-Device Identifier: 05037881027043
• UDI-Public: 05037881027043
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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: THA3034X150A
• Device Lot Number: 25300774
• 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: 07/02/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2023
• 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 Age: 58 YR
• Patient Sex: Female