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

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	Thrombocytopenia (4431)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical code: 4431 - thrombocytophenia: the site reported the event as thrombocytopenia.Impact code: 4648 - insufficient information: awaiting information from the site.Medical device problem: 3190 - insufficient information: awaiting information from the site.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 3331 - analysis of production records: to be performed.4110 - trend analysis: 4 year review was performed for thoraflex hybrid > medical event > nature of event (thrombocytopenia), this gave an occurrence rate of (b)(4).No trend identified that required action at this time.4111 - communication/interviews: additional information has been requested, waiting on information from the site.4117 - device no accessible for testing: the device remains implanted.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusion: 11 - conclusion not yet available.
Event or Problem Description
Event reported by clinical trial: extend: (b)(4).On post operative day 1 (on (b)(6) 2025), an adverse event (ae) of thrombocytopenia was reported by site for subject: (b)(6) - further comments detail "low platelet count".Outcome of the ae is ongoing at time of reporting, with status of unresolved not treating.Concomitant medications are not listed at time of reporting; site will be requested to complete as soon as possible.
Additional Manufacturer Narrative
Clinical code: 4431 - thrombocytophenia : the site reported the event as thrombocytopenia.Impact code: 4648 - insufficent information : no information was provided by the site for impact code.Medical device problem: 2993 - adverse event without identified device or use problem: from the information provided we can confirm there was no issues with the device before or during implant and from the imaging in this case there's nothing on the scans to suggest the device caused or contributed to the low platelet count.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 3331 - analysis of production records: comprehensive batch review had been performed; no issue were identified during manufacture of this device.Device manufactured to specification.4110 - trend analysis: 4 year review was performed for thoraflex hybrid medical event nature of event (thrombocytopenia), this gave an occurrence rate of (b)(4).No trend identified that required action at this time.4111 - communication/interviews: additional information was received which stated the below: · within the study report the graft remined patent.· there was no issues with the device before or during implant.· the site reported the event within study protocol as non-serious adverse event.· the event was unanticipated.4117 - device no accessible for testing: the device remains implanted.4112 - analysis of information provided by user/third party: based on the imaging, there is no evidence of a problem with the device itself, such as poor placement, damage, or blood clots forming inside the graft.While imaging can help rule out some rare device-related issues, in this case there's nothing on the scans to suggest the device caused or contributed to the low platelet count.Investigation findings: 213 - no device problem found: from the information provided we can confirm there was no issues with the device before or during implant and from the imaging in this case there's nothing on the scans to suggest the device caused or contributed to the low platelet count.Investigation conclusion: 4310 - cause traced to non-device related factors: from the information provided we can confirm there was no issues with the device before or during implant and from the imaging in this case there's nothing on the scans to suggest the device caused or contributed to the low platelet count.4323 - device problem excluded: from the information provided we can confirm there was no issues with the device before or during implant and from the imaging in this case there's nothing on the scans to suggest the device caused or contributed to the low platelet count.22 - known inherent risk of device: ifu review was performed which confirmed that within thoraflex hybrid us ifu (301-213-usen) rev 2.0 section 6.1 table 2 potential adverse events mentions thrombocytopenia.
Event or Problem Description
Event reported by clinical trial : extend - (b)(6).On post operative day 1 ((b)(6) 2025), an adverse event (ae) of thrombocytopenia was reported by site for subject (b)(6) - further comments detail "low platelet count".Outcome of the ae is ongoing at time of reporting, with status of unresolved not treating.Concomitant medications are not listed at time of reporting, site will be requested to complete as soon as possible.This report is being submitted as follow up 1 for manufacturing report number to provide event closure information for tag0254.

• Brand Name: THORAFLES 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: 22174010
• Report Number: 9612515-2025-00058
• Device Sequence Number: 7799058
• Product Code: QSK
• UDI-Device Identifier: 05037881026923
• UDI-Public: 05037881026923
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Study
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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: THA2830X100A
• Device Lot Number: 25150734
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2022
• 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: Other
• Patient Age: 74 YR
• Patient Sex: Female