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

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	07/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Event reported from extend-001 (nct05639400) post market approval study.Thoraflex hybrid plexus was implanted in a 52-year-old (at the time of consent) male patient, indication for surgery: chronic dissection (debakey type iiib) and post-dissection aneurysm.Implant date (b)(6) 2024.Event date 31 jul 24, 34 days from procedure.No source/medical notes have been uploaded into the study database for this event so far.The site reported the event of pseudoaneurysm (description: innominate artery pseudoaneurysm) as possibly related to the thoraflex hybrid device, related to the procedure, and not related to a pre-existing condition.Treatment was reported as "stent placement-subclavian artery".Note, no device deficiency form has been completed by the site to date.The outcome has not yet been provided in the study database.The subject remains in the study.
Additional Manufacturer Narrative
Manufactures narrative: clinical code: 2605-pseudoaneurym: the event was report as a pseudoaneurysm on the event intake form.Impact code: 4624 - surgical intervention: treatment was reported as "stent placement-subclavian artery" device problem code: 3190 - insufficient information: awaiting further information regarding device problem from the site.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4111 - communication/interview: awaiting further information from the site.4117 - device not accessible for testing: device remains implanted.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusion: 11 - cause not yet established.
Additional Manufacturer Narrative
Manufactures narrative: clinical code: 2605- pseudoaneurysm reported.Impact code: 4624 - surgical intervention: treatment - "stent placement-innominate artery." device problem code: 2993 - no device problem found -the site confirmed there was no device deficiency.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110- a 4 year similar event review was performed for thoraflex hybrid sales jan 21 - aug 24 v thoraflex hybrid pseudo-aneurysm events (b)(6) 2024 which gave an occurrence rate of (b)(4) (sales v complaints).No trend requiring action has been identified.4111 - communication/interview; additional information was received on 23 sep 24, the pseudoaneurysm located at the anastomosis between the graft and innominate artery is stable due to treatment, there was no abnormal leakage from the graft during implant.Atraumatic clamps were used in the procedure, the event was not related to a device deficiency.The patient was treated with stent of the innominate artery with no residual leak.4112 - analysis of information provided by site - confirmation there was no device deficiency.4117 - device not accessible for testing - the device remains implanted.Investigation findings: 213 - full batch review was performed from base fabric to finished product which showed the device was manufactured to specification.The site confirmed there was no device deficiency.Investigation conclusion: 4311 - as the event was reported as related the procedure and possibly device related and the site confirmed this was no device deficiency and full batch review was performed which showed the device was manufactured to specification, we have deemed this event to be procedure related.Additional information: removed patient age fromsection a2 as this was the age at time of consent to join the study, not at the time of event.
Event or Problem Description
Event reported from extend-001 (b)(6) post market approval study.Thoraflex hybrid plexus was implanted in a 52 year old ( at the time of consent) male patient, indication for surgery: chronic dissection (debakey type iiib) and post-dissection aneurysm.Implant date (b)(6) 2024.Event date 31 jul 2024, 34 days from procedure.No source/medical notes have been uploaded into the study database for this event so far.The site reported the event of pseudoaneurysm (description: innominate artery pseudoaneurysm) as possibly related to the thoraflex hybrid device, related to the procedure, and not related to a pre-existing condition.Treatment was reported as "stent placement-subclavian artery".Note, no device deficiency form has been completed by the site to date.The outcome has not yet been provided in the study database.The subject remains in the study.This report is being submitted as follow up #1 for mfg.Report number 96125152024-00055 to provide event closure information for tag0026.

• Brand Name: THORAFLEX HYBRID
• Common Device Name: THORAFLEX HYBRID PLEXUS
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan buisness park; glasgow, renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 20074101
• Report Number: 9612515-2024-00055
• Device Sequence Number: 12363391
• Product Code: QSK
• UDI-Device Identifier: 05037881026701
• UDI-Public: 05037881026701
• 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): 10/30/2024

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 Expiration Date: 04/30/2026
• Device Model Number: N/A
• Device Catalogue Number: THP2628X100A
• Device Lot Number: 25469180
• 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: 08/09/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2023
• 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: 52 YR
• Patient Sex: Male